Quality Assurance

Our Policy

Ortho Technology is committed to Quality and to operating an effective Quality Management System. It is our policy to use this commitment to provide Orthodontic products that meet our customers’ requirements and to comply with ISO 13485, FDA, MDD, CMDR, HSA and other globally recognized standards and accepted industry practices. It will be Executive Management’s responsibility to implement and provide the resources to meet the quality objectives. All Ortho Technology employees will accept responsibility for the quality of service and take professional pride in providing quality Orthodontic products, while maintaining our Quality Objectives.


ISO 13485:2003ISO 13485
ISO is a network of the national standards institutes of 148 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. International Standards provide a reference framework, or a common technological language, between suppliers and their customers – which facilitates trade and the transfer of technology.


ukasUKAS
The United Kingdom Accreditation Service is the sole national accreditation body recognized by government to assess, against internationally agreed standards, organizations that provide certification, testing, inspection and calibration services. Accreditation by UKAS demonstrates the competence, impartiality and performance capability of these evaluators. UKAS is a non-profit-distributing company, limited by guarantee, and operates under a Memorandum of Understanding with the Government through the Secretary of State for Trade and Industry.


ce markCE Mark for EU Member Countries
The CE mark is the official marking required by the European Community. It proves to the buyer -or user- that this product fulfills all essential safety and environmental requirements as they are defined in the European Directives.


fda logoFood and Drug Administration
U.S. Department of Health and Human Services
The FDA’s mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. The FDA is a blending of law and science aimed at protecting consumers.

Certificates for Foreign Government
While FDA does not place any restrictions on the export of medical devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). These export certifications were formerly referred to as a Certificate for Products for Export or Certificate of Free Sale. The CFG is a self certification process that is used to speed the processing of requests. Ortho Technology has obtained Certificates to Foreign Government and will furnish upon customer request. Please contact Maria White [email protected], our Global Customer Service Manager, if you need an original CFG.

FDA UPDATES
Retainer and Denture Cleansers: Allergic Reactions and Misuse
FDA is asking manufacturers of denture cleansers to include a warning in the label about persulfates, which are known to cause allergic reactions in some people. Click for full article.


health-canada-logo
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.


MSDS Icon Material Safety Data Sheets
U.S. Department of Labor Occupational Safety and Health Administration
In 1988, the Department of Labor passed the Occupational Safety and Health Act (OSHA). In order to ensure chemical safety in the workplace, information must be available about the identities and hazards of the chemicals used in your workplace. OSHA’s Hazard Communication Standard (HCS) requires the development and dissemination of such information through Material Safety Data Sheets.

Material Safety Data Sheets

FileUSAEuropeCanada
Clear Advantage Coping Material
Clear_Advantage_Coping_Material.pdfClear_Advantage_Coping_Material_EU_Format.pdfClear_Advantage_Coping_Material_Canada_Format.pdf
Clear Advantage Splint Material
Clear_Advantage_Splint_Material.pdfClear_Advantage_Splint_Material_EU_Format.pdfClear_Advantage_Splint_Material_Canada_Format.pdf
DSX Medic 365 Lubricant
DSX_Medic_365_Lubricant.pdfDSX_Medic_365_Lubricant_EU_Format.pdfDSX_Medic_365_Lubricant_Canada_Format.pdf
ExaBite II NDS Registration Base
ExaBite_II_NDS_Registration_Base.pdfExaBite_II_NDS_Registration_Base.pdfExaBite_II_NDS_Registration_Base.pdf
ExaBite II NDS Registration Catalyst
ExaBite_II_NDS_Registration_Catalyst.pdfExaBite_II_NDS_Registration_Catalyst.pdfExaBite_II_NDS_Registration_Catalyst.pdf
ExaFast NDS Regular, Monophase, Heavy, Injection Base
ExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Base.pdfExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Base.pdfExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Base.pdf
ExaFast NDS Regular, Monophase, Heavy, Injection Catalyst
ExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Catalyst.pdfExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Catalyst.pdfExaFast_NDS_Regular,_Monophase,_Heavy,_Injection_Catalyst.pdf
ExaFast Putty Base and Catalyst
ExaFast_Putty_Base_and_Catalyst.pdfExaFast_Putty_Base_and_Catalyst.pdfExaFast_Putty_Base_and_Catalyst.pdf
Exajet Heavy Body Base
Exajet_Heavy_Body_Base.pdfExajet_Heavy_Body_Base.pdfExajet_Heavy_Body_Base.pdf
Exajet Heavy Body Catalyst
Exajet_Heavy_Body_Catalyst.pdfExajet_Heavy_Body_Catalyst.pdfExajet_Heavy_Body_Catalyst.pdf
Fuji Ortho Band LC Paste Pak Automix Paste B
Fuji_Ortho_Band_LC_Paste_Pak_Automix_Paste_B.pdfFuji_Ortho_Band_LC_Paste_Pak_Automix_Paste_B.pdfFuji_Ortho_Band_LC_Paste_Pak_Automix_Paste_B.pdf
Fuji Ortho Band LC Paste Pak Automix Paste A
Fuji_Ortho_Band_LC_Paste_Pak__Automix__Paste_A.pdfFuji_Ortho_Band_LC_Paste_Pak__Automix__Paste_A.pdfFuji_Ortho_Band_LC_Paste_Pak__Automix__Paste_A.pdf
Fuji Ortho Band Paste Pak Paste A
Fuji_Ortho_Band_Paste_Pak_Paste_A.pdfFuji_Ortho_Band_Paste_Pak_Paste_A.pdfFuji_Ortho_Band_Paste_Pak_Paste_A.pdf
Fuji Ortho Band Paste Pak Paste B
Fuji_Ortho_Band_Paste_Pak_Paste_B.pdfFuji_Ortho_Band_Paste_Pak_Paste_B.pdfFuji_Ortho_Band_Paste_Pak_Paste_B.pdf
Fuji Ortho LC Paste Pak Automix Paste A
Fuji_Ortho_LC_Paste_Pak_Automix_Paste_A.pdfFuji_Ortho_LC_Paste_Pak_Automix_Paste_A.pdfFuji_Ortho_LC_Paste_Pak_Automix_Paste_A.pdf
Fuji Ortho LC Paste Pak Automix Paste B
Fuji_Ortho_LC_Paste_Pak_Automix_Paste_B.pdfFuji_Ortho_LC_Paste_Pak_Automix_Paste_B.pdfFuji_Ortho_LC_Paste_Pak_Automix_Paste_B.pdf
GC Fuji I Kit and Capsules Liquid
GC_Fuji_I_Kit_and_Capsules_Liquid.pdfGC_Fuji_I_Kit_and_Capsules_Liquid.pdfGC_Fuji_I_Kit_and_Capsules_Liquid.pdf
GC Fuji I Kit and Capsules Powder
GC_Fuji_I__Kit_and_Capsules_Powder.pdfGC_Fuji_I__Kit_and_Capsules_Powder.pdfGC_Fuji_I__Kit_and_Capsules_Powder.pdf
GC Fuji Ortho Gel Conditioner
GC_Fuji_Ortho_Gel_Conditioner.pdfGC_Fuji_Ortho_Gel_Conditioner.pdfGC_Fuji_Ortho_Gel_Conditioner.pdf
GC Fuji Ortho LC Kit and Capsules Powder
GC_Fuji_Ortho_LC_Kit_and_Capsules_Powder.pdfGC_Fuji_Ortho_LC_Kit_and_Capsules_Powder.pdfGC_Fuji_Ortho_LC_Kit_and_Capsules_Powder.pdf
GC Fuji Ortho LC Kit and Capsules Liquid
GC_Fuji_Ortho_LC_Kit_and_Capsules__Liquid.pdfGC_Fuji_Ortho_LC_Kit_and_Capsules__Liquid.pdfGC_Fuji_Ortho_LC_Kit_and_Capsules__Liquid.pdf
GC Fuji Ortho Self Cure Liquid
GC_Fuji_Ortho_Self_Cure_Liquid.pdfGC_Fuji_Ortho_Self_Cure_Liquid.pdfGC_Fuji_Ortho_Self_Cure_Liquid.pdf
GC Fuji Ortho Self Cure Powder
GC_Fuji_Ortho_Self_Cure_Powder.pdfGC_Fuji_Ortho_Self_Cure_Powder.pdfGC_Fuji_Ortho_Self_Cure_Powder.pdf
GC Ortho Conditioner
GC_Ortho_Conditioner.pdfGC_Ortho_Conditioner.pdfGC_Ortho_Conditioner.pdf
Hydrogel Fast Set Alginate
Hydrogel_Fast_Set_Alginate.pdfHydrogel_Fast_Set_Alginate_EU_Format.pdfHydrogel_Fast_Set_Alginate_Canada_Format.pdf
Kodak GBX Twin Pack Developer
Kodak_GBX_Twin_Pack_Developer.pdfKodak_GBX_Twin_Pack_Developer.pdfKodak_GBX_Twin_Pack_Developer.pdf
Kodak GBX Twin Pack Fixer
Kodak_GBX_Twin_Pack_Fixer.pdfKodak_GBX_Twin_Pack_Fixer.pdfKodak_GBX_Twin_Pack_Fixer.pdf
Kodak Readymatic ChemPack Fixer
Kodak_Readymatic_ChemPack_Fixer.pdfKodak_Readymatic_ChemPack_Fixer.pdfKodak_Readymatic_ChemPack_Fixer.pdf
Kodak Readymatic ChemPack Developer
Kodak__Readymatic_ChemPack_Developer.pdfKodak__Readymatic_ChemPack_Developer.pdfKodak__Readymatic_ChemPack_Developer.pdf
KROMOPAN 100
KROMOPAN_100.pdfKROMOPAN_100.pdfKROMOPAN_100.pdf
Medica 28 Plus Cold Sterilant
Medica_28_Plus_Cold_Sterilant.pdfMedica_28_Plus_Cold_Sterilant.pdfMedica_28_Plus_Cold_Sterilant.pdf
Metal Primer
Metal_Primer.pdfMetal_Primer.pdfMetal_Primer_Canada_Format.pdf
Model Glow
Model_Glow.pdfModel_Glow.pdfModel_Glow.pdf
Orthodontic Plaster
Orthodontic_Plaster.pdfOrthodontic_Plaster.pdfOrthodontic_Plaster.pdf
Orthodontic Stone
Orthodontic_Stone.pdfOrthodontic_Stone.pdfOrthodontic_Stone.pdf
Orthoprint Fast Set Alginate
Orthoprint_Fast_Set_Alginate.pdfOrthoprint_Fast_Set_Alginate.pdfOrthoprint_Fast_Set_Alginate.pdf
Plastic Conditioner
Plastic_Conditioner.pdfPlastic_Conditioner_EU_Format.pdfPlastic_Conditioner_Canada_Format.pdf
Porcelain Conditioner
Porcelain_Conditioner.pdfPorcelain_Conditioner_EU_Format.pdfPorcelain_Conditioner_Canada_Format.pdf
Prophy Paste
Prophy_Paste.pdfProphy_Paste_EU_Format.pdfProphy_Paste_Canada_Format.pdf
Prospec MI Paste
Prospec_MI_Paste.pdfProspec_MI_Paste.pdfProspec_MI_Paste.pdf
Prospec MI Paste Plus
Prospec_MI_Paste_Plus.pdfProspec_MI_Paste_Plus.pdfProspec_MI_Paste_Plus.pdf
Redi-Prep Etchant Swabs
Redi-Prep_Etchant_Swabs.pdfRedi-Prep_Etchant_Swabs_Eu_Format.pdfRedi-Prep_Etchant_Swabs_Canada_Format.pdf
Resilience Chemical-Activated Adhesive Base Paste
Resilience_Chemical-Activated_Adhesive_Base_Paste.pdfResilience_Chemical-activated_Adhesive_Base_Paste_EU_Format.pdfResilience_Chemical-activated_Adhesive_Base_Paste_Canada_Format.pdf
Resilience Chemical Cure Adhesive Catalyst
Resilience_Chemical_Cure_Adhesive_Catalyst.pdfResilience_Chemical_Cure_Adhesive_Catalyst_EU_Format.pdfResilience_Chemical_Cure_Adhesive_Catalyst_Canada_Format.pdf
Resilience Enamel Bonding Resin Base Liquid
Resilience_Enamel_Bonding_Resin_Base_Liquid.pdfResilience_Enamel_Bonding_Resin_Base_Liquid_EU_Format.pdfResilience_Enamel_Bonding_Resin_Base_Liquid_Canada_Format.pdf
Resilience Enamel Catalyst Primer
Resilience_Enamel_Catalyst_Primer.pdfResilience_Enamel_Catalyst_Primer_EU_Format.pdfResilience_Enamel_Catalyst_Primer_Canada_Format.pdf
Resilience Gel Etchant
Resilience_Gel_Etchant.pdfResilience_Gel_Etchant.pdfResilience_Gel_Etchant_Canada_Format.pdf
Resilience Glass Ionomer Liquid Band Cement
Resilience_Glass_Ionomer_Liquid_Band_Cement.pdfResilience_Glass_Ionomer_Liquid_Band_Cement_EU_Format.pdfResilience_Glass_Ionomer_Liquid_Band_Cement_Canada_Format.pdf
Resilience Glass Ionomer Powder
Resilience_Glass_Ionomer_Powder.pdfResilience_Glass_Ionomer_Powder_EU_Format.pdfResilience_Glass_Ionomer_Powder_Canada_Format.pdf
Resilience Light-Cure Band Cement Blue Shade
Resilience_Light-Cure_Band_Cement_Blue_Shade.pdfResilience_Light-Cure_Band_Cement_Blue_Shade_EU_Format.pdfResilience_Light-Cure_Band_Cement_Blue_Shade_Canada_Format.pdf
Resilience Light-Cure Bracket Adhesive
Resilience_Light-Cure_Bracket_Adhesive.pdfResilience_Light-Cure_Bracket_Adhesive_EU_Format.pdfResilience_Light-Cure_Bracket_Adhesive_Canada_Format.pdf
Resilience Liquid Etch
Resilience_Liquid_Etch.pdfResilience_Liquid_Etch.pdfResilience_Liquid_Etch_Canada_Format.pdf
Resilience Low Viscosity Light-Cure Flowable Composite
Resilience_Low_Viscosity_Light-Cure_Flowable_Composite.pdfResilience_Low_Viscosity_Light-Cure_Flowable_Composite_EU_Format.pdfResilience_Low_Viscosity_Light-Cure_Flowable_Composite_Canada_Format.pdf
Resilience Multi-Cure Glass Ionomer Base Adhesive
Resilience_Multi-Cure_Glass_Ionomer_Base_Adhesive.pdfResilience_Multi-Cure_Glass_Ionomer_Base_Adhesive_EU_Format.pdfResilience_Multi-Cure_Glass_Ionomer_Base_Adhesive_Canada_Format.pdf
Resilience Multi-Cure Glass Ionomer Catalyst Paste
Resilience_Multi-Cure_Glass_Ionomer_Catalyst_Paste.pdfResilience_Multi-Cure_Glass_Ionomer_Catalyst_Paste_EU_Format.pdfResilience_Multi-Cure_Glass_Ionomer_Catalyst_Paste_Canada_Format.pdf
Resilience Primer-Activated Adhesive
Resilience_Primer-Activated_Adhesive.pdfResilience_Primer-Activated_Adhesive_EU_Format.pdfResilience_Primer-Activated_Adhesive_Canada_Format.pdf
Resilience Sealant Resin
Resilience_Sealant_Resin.pdfResilience_Sealant_Resin_EU_Format.pdfResilience_Sealant_Resin_Canada_Format.pdf
Silver Solder
Silver_Solder.pdfSilver_Solder_EU_Format.pdfSilver_Solder_Canada_Format.pdf
Smoothex Debubbling Solution
Smoothex_Debubbling_Solution.pdfSmoothex_Debubbling_Solution.pdfSmoothex_Debubbling_Solution.pdf
Sports Advantage Mouthguard Material
Sports_Advantage_Mouthguard_Material.pdfSports_Advantage_Mouthguard_Material_EU_Format.pdfSports_Advantage_Mouthguard_Material_Canada_Format.pdf
Tastes Great Alginate Flavoring
Tastes_Great_Alginate_Flavoring.pdfTastes_Great_Alginate_Flavoring_EU_Format.pdfTastes_Great_Alginate_Flavoring_Canada_Format.pdf
Tropicalgin Chromatic Alginate
Tropicalgin_Chromatic_Alginate.pdfTropicalgin_Chromatic_Alginate.pdfTropicalgin_Chromatic_Alginate.pdf
TruAcrylic Monomer Orthodontic Acrylic Liquid
TruAcrylic_Monomer_Orthodontic_Acrylic_Liquid.pdfTruAcrylic_Monomer_Orthodontic_Acrylic_Liquid_EU_Format.pdfTruAcrylic_Monomer_Orthodontic_Acrylic_Liquid_Canada_Format.pdf
TruAcrylic Polymer Orthodontic Acrylic Powder
TruAcrylic_Polymer_Orthodontic_Acrylic_Powder.pdfTruAcrylic_Polymer_Orthodontic_Powder_EU_Format.pdfTruAcrylic_Polymer_Orthodontic_Powder_Canada_Format.pdf
TruEtch Aluminum Oxide
TruEtch_Aluminum_Oxide.pdfTruEtch_Aluminum_Oxide_EU_Format.pdfTruEtch_Aluminum_Oxide_Canada_Format.pdf
TruFlow Orthodontic Flux
TruFlow_Orthodontic_Flux.pdfTruFlow_Orthodontic_Flux_Eu_Format.pdfTruFlow_Orthodontic_Flux_Canada_Format.pdf
TruTack Brush-on Tray Adhesive
TruTack_Brush-on_Tray_Adhesive.pdfTruTack_Tray_Adhesive_Brush-on_EU_Format.pdfTruTack_Tray_Adhesive_Brush-on_Canada_Format.pdf
TruTack Tray Adhesive Spray
TruTack_Tray_Adhesive_Spray.pdfTruTack_Tray_Adhesive_Spray_EU_Format.pdfTruTack_Tray_Adhesive_Spray_Canada_Format.pdf
TruVision Automatic Processing Developer
TruVision_Automatic_Processing_Developer.pdfTruVision_Automatic_Processing_Developer.pdfTruVision_Automatic_Processing_Developer.pdf
TruVision Automatic Processing Fixer
TruVision_Automatic_Processing_Fixer.pdfTruVision_Automatic_Processing_Fixer.pdfTruVision_Automatic_Processing_Fixer.pdf
TruVision Manual Processing Concentrated Developer
TruVision_Manual_Processing_Concentrated_Developer.pdfTruVision_Manual_Processing_Concentrated_Developer.pdfTruVision_Manual_Processing_Concentrated_Developer.pdf
TruVision Manual Processing Concentrated Fixer
TruVision_Manual_Processing_Concentrated_Fixer.pdfTruVision_Manual_Processing_Concentrated_Fixer.pdfTruVision_Manual_Processing_Concentrated_Fixer.pdf
Universal All-In-One Solder Flux
Universal_All-In-One_Solder_Flux.pdfUniversal_All-In-One_Solder_Flux_EU_Format.pdfUniversal_All-In-One_Solder_Flux_Canada_Format.pdf
Viraguard Disinfectant
Viraguard_Disinfectant.pdfViraguard_Disinfectant.pdfViraguard_Disinfectant.pdf
Wonderfill Tongue Filler
Wonderfill_Tongue_Filler.pdfWonderfill_Tongue_Filler.pdfWonderfill_Tongue_Filler.pdf

Material Data Safety Exemptions

An “article” under the Hazard Communication Standard (Subpart Z, Toxic and Hazardous Substances, 29 CFR 1910.1200) is any manufactured item other than a fluid or particle which, 1) is formed to a specific shape or design during manufacture, 2) has end use function(s) dependent in whole or in part upon its shape or design during end use, and 3) which under normal conditions of use does not pose a physical hazard or health risk to employees. The following Ortho Technology products are considered “articles” under the OSHA Standard and therefore do not require SDS because they do not release, or otherwise result in exposure to a hazardous chemical under normal conditions of use:

All Stainless Steel, Nickel Titanium and Beta Titanium products
Molar Bands and Assemblies
Bonding Brushes and Accessories
Bracket Systems to include all Ceramic, Composite, Gold Plated, Stainless Steel varieties
Buccal Tubes
Burs, Discs, Interproximal Strips and Accessories
Curing Lights
Elastomeric Products
Eruption Appliances and Attachments
Headgear and Accessories
Impression Trays
Molar Bands
Mouthguards and Mouthguard forming materials
Orthodontic Anchorage Systems
Orthodontic Instruments and Accessories
Patient Accessories (Toothbrush, Dental Floss, Relief Wax, etc.)
Retractors
Wire Products


Product Instructions for Use
Ortho Technology supplies Instructions for Use in multiple languages with our products. If you require additional instructions, they are available for download in PDF format.

Product

PDF
Cybird XD Advanced LED Curing LightCybird XD Curing Light
Encore! Metal-Lined Ceramic BracketsEncore! Metal-Lined Ceramic Bracket System
EZ Space MaintainerEZ Space Maintainer
Güray Bite RaiserGuray Bite Raiser
Lotus Plus Passive Self-Ligating BracketsLotus Plus Passive Self-Ligating Brackets
Lotus Plus Replacement ClipLotus Plus Replacement Clip
Microetcher II & IIAMicroetcher II & IIA
MiniStripperMini Stripper
Mold-A-LateralMold-A-Lateral
Ortho Model Archival System Front LoadingOrtho Model Archival System Front Loading
Ortho Model Archival System Top LoadingOrtho Model Archival System Top Loading
Orthodontic Instrument Sterilization ProceduresOrthodontic Instrument Sterilization Procedures
Pure Sapphire BracketsPure Sapphire Bracket System
Reflections Ceramic BracketsReflections Ceramic Bracket System
Resilience Multi-Cure Band CementResilience Light-Cure Band Cement
Resilience Glass Ionomer Powder/Liquid Band CementResilience Glass Ionomer Powder/Liquid Band Cement
Resilience Light-Cure Band CementResilience Light-Cure Band Cement
Resilience Light-Cure Orthodontic Bracket AdhesiveResilience Light-Activated Orthodontic Bonding Systems
Resilience Low Viscosity Light-Cure Flowable CompositeResilience Low Viscosity Light-Cure Flowable Composite
Resilience No Mix Orthodontic Bracket AdhesiveResilience Primer-Activated Orthodontic Bonding Systems
Retainer BriteRetainer Brite
Sensation Active Ceramic Self-Ligating BracketsSensation Active Ceramic Self-Ligating Brackets
Sensation M Active Stainless Steel Self-Ligating BracketsSensation M Active Stainless Self-Ligating Brackets
Spider ScrewSpider Screw
Sunstar GUM Rincinol P.R.N.Sunstar GUM Rincinol P.R.N.
Torque DriverTorque Driver
X7 Orthodontic InstrumentsResilience Light-Activated Orthodontic Bonding Systems

For more information about ISO, FDA, Certificate to Foreign Government (CFG), or CE related inquiries, please contact:

Brian Kuess
Director of Regulatory Affairs/Quality Assurance
[email protected]

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