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
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.
- Download 616874_issue 1 UKAS
- Download SGS MDSAP 2019
- Download 616874_issue 1 MDD Annex II excluding Section 4
UKAS
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 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.
Food 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 mariaw@orthotechnology.com, 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 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.
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
| File | USA | Europe | Canada |
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| Clear Advantage Coping Material |
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| Clear Advantage Splint Material |
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| DSX Medic 365 Lubricant |
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| ExaBite II NDS Registration Base |
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| ExaBite II NDS Registration Catalyst |
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| ExaFast NDS Regular, Monophase, Heavy, Injection Base |
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| ExaFast NDS Regular, Monophase, Heavy, Injection Catalyst |
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| ExaFast Putty Base and Catalyst |
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| Exajet Heavy Body Base |
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| Exajet Heavy Body Catalyst |
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| Fuji Ortho Band LC Paste Pak Automix Paste B |
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| Fuji Ortho Band LC Paste Pak Automix Paste A |
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| Fuji Ortho Band Paste Pak Paste A |
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| Fuji Ortho Band Paste Pak Paste B |
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| Fuji Ortho LC Paste Pak Automix Paste A |
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| Fuji Ortho LC Paste Pak Automix Paste B |
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| GC Fuji I Kit and Capsules Liquid |
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| GC Fuji I Kit and Capsules Powder |
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| GC Fuji Ortho Gel Conditioner |
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| GC Fuji Ortho LC Kit and Capsules Powder |
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| GC Fuji Ortho LC Kit and Capsules Liquid |
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| GC Fuji Ortho Self Cure Liquid |
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| GC Fuji Ortho Self Cure Powder |
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| GC Ortho Conditioner |
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| Hydrogel Fast Set Alginate |
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| Kodak GBX Twin Pack Developer |
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| Kodak GBX Twin Pack Fixer |
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| Kodak Readymatic ChemPack Fixer |
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| Kodak Readymatic ChemPack Developer |
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| KROMOPAN 100 |
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| Medica 28 Plus Cold Sterilant |
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| Metal Primer |
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| Model Glow |
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| Orthodontic Plaster |
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| Orthodontic Stone |
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| Orthoprint Fast Set Alginate |
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| Plastic Conditioner |
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| Porcelain Conditioner |
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| Prophy Paste |
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| Prospec MI Paste |
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| Prospec MI Paste Plus |
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| Redi-Prep Etchant Swabs |
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| Resilience Chemical-Activated Adhesive Base Paste |
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| Resilience Chemical Cure Adhesive Catalyst |
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| Resilience Enamel Bonding Resin Base Liquid |
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| Resilience Enamel Catalyst Primer |
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| Resilience Gel Etchant |
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| Resilience Glass Ionomer Liquid Band Cement |
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| Resilience Glass Ionomer Powder |
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| Resilience Light-Cure Band Cement Blue Shade |
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| Resilience Light-Cure Bracket Adhesive |
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| Resilience Liquid Etch |
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| Resilience Low Viscosity Light-Cure Flowable Composite |
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| Resilience Multi-Cure Glass Ionomer Base Adhesive |
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| Resilience Multi-Cure Glass Ionomer Catalyst Paste |
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| Resilience Primer-Activated Adhesive |
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| Resilience Sealant Resin |
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| Silver Solder |
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| Smoothex Debubbling Solution |
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| Sports Advantage Mouthguard Material |
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| Tastes Great Alginate Flavoring |
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| Tropicalgin Chromatic Alginate |
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| TruAcrylic Monomer Orthodontic Acrylic Liquid |
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| TruAcrylic Polymer Orthodontic Acrylic Powder |
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| TruEtch Aluminum Oxide |
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| TruFlow Orthodontic Flux |
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| TruTack Brush-on Tray Adhesive |
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| TruTack Tray Adhesive Spray |
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| TruVision Automatic Processing Developer |
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| TruVision Automatic Processing Fixer |
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| TruVision Manual Processing Concentrated Developer |
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| TruVision Manual Processing Concentrated Fixer |
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| Universal All-In-One Solder Flux |
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| Viraguard Disinfectant |
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| Wonderfill Tongue Filler |
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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.
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Product |
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| Cybird XD Advanced LED Curing Light | |
| Encore! Metal-Lined Ceramic Brackets | |
| EZ Space Maintainer | |
| Güray Bite Raiser | |
| Lotus Plus Passive Self-Ligating Brackets | |
| Lotus Plus Replacement Clip | |
| Microetcher II & IIA | |
| MiniStripper | |
| Mold-A-Lateral | |
| Ortho Model Archival System Front Loading | |
| Ortho Model Archival System Top Loading | |
| Orthodontic Instrument Sterilization Procedures | |
| Pure Sapphire Brackets | |
| Reflections Ceramic Brackets | |
| Resilience Multi-Cure Band Cement | |
| Resilience Glass Ionomer Powder/Liquid Band Cement | |
| Resilience Light-Cure Band Cement | |
| Resilience Light-Cure Orthodontic Bracket Adhesive | |
| Resilience Low Viscosity Light-Cure Flowable Composite | |
| Resilience No Mix Orthodontic Bracket Adhesive | |
| Retainer Brite | |
| Sensation Active Ceramic Self-Ligating Brackets | |
| Sensation M Active Stainless Steel Self-Ligating Brackets | |
| Spider Screw | |
| Sunstar GUM Rincinol P.R.N. | |
| Torque Driver | |
| X7 Orthodontic Instruments | |
| For more information about ISO, FDA, Certificate to Foreign Government (CFG), or CE related inquiries, please contact:
Brian Kuess |