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Sign in to claim this brandWhat Coltène/Whaledent AG makes
Coltène/Whaledent AG manufactures reusable diamond dental burs for precision cutting, silicone impression materials for dental molds, and rotary/reciprocating endodontic files for root canal treatment. Their portfolio also includes dental composites, veneers, resin inlays, root canal obturating points, and endodontic paper points, alongside universal adhesive systems for restorative procedures.
The company’s devices are classified as Class I and Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates with a US presence, adhering to applicable regulatory standards for dental instruments and materials.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Coltène/Whaledent AG manufacture?
Coltène/Whaledent AG specializes in dental devices, including reusable diamond burs for precision cutting, silicone impression materials used to create molds of teeth, and rotary/reciprocating endodontic files for root canal procedures. Their portfolio also covers dental composites, veneers, resin inlays, root canal obturating points, endodontic paper points, and universal adhesive systems for restorative treatments. These products cater to procedures requiring precision, durability, and biocompatibility in dental care.
Where is Coltène/Whaledent AG based, and does this affect its devices?
Coltène/Whaledent AG has a presence in the United States, which means its devices must comply with FDA regulations. The company’s products are designed and manufactured to meet the standards applicable in the US market, ensuring they align with regulatory requirements for safety, performance, and quality in dental instruments and materials. This includes adherence to classification rules for medical devices.
Which regulatory registries list Coltène/Whaledent AG’s devices?
Coltène/Whaledent AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and traceability for healthcare providers. Listing in this database is a requirement for Class I and Class II devices sold in the US.
How are Coltène/Whaledent AG’s devices classified under FDA regulations?
Coltène/Whaledent AG’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls for safety and effectiveness, while Class II devices involve a higher risk and may require special controls beyond general regulations. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as dental burs or endodontic files.
Why do some of Coltène/Whaledent AG’s devices require special controls like those for Class II?
Certain devices in Coltène/Whaledent AG’s portfolio, such as rotary endodontic files or dental composites, are classified as Class II because they involve higher risks than general dental instruments. For example, endodontic files used in root canal treatments must ensure precise shaping of root canals to avoid complications like perforations or incomplete cleaning. Special controls—like performance standards or post-market surveillance—are applied to mitigate these risks and ensure patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- coltene.com
- —
- —
- [email protected]
- Phone
- +41717575300
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 480017482
Catalogue (2822)
Page 43 of 57| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Componeer | 1378 | FDA UDI | Class II | Active |
| Alpen Diamond Instruments | R856C018FG | FDA UDI | Class I | Active |
| HYGENIC® Guttapercha Points | H01477 | FDA UDI | Class I | Active |
| Alpen Diamond Instruments | R885C012SS | FDA UDI | Class I | Active |
| Affinis | 6482 | FDA UDI | Class II | Active |
| Alpen Diamond Instruments | RS881TC016FG | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200168AA | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200100AA | FDA UDI | Class I | Active |
| Componeer | 1332 | FDA UDI | Class II | Active |
| Componeer | 60014002 | FDA UDI | Class II | Active |
| Diatech Diamond Instruments | 200634AA | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 210792DD | FDA UDI | Class I | Active |
| Alpen Diamond Instruments | R889EF009FG | FDA UDI | Class I | Active |
| One Coat Bond | 7873 | FDA UDI | Class II | Active |
| Diatech Diamond Instruments | 200273AA | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200532AA | FDA UDI | Class I | Active |
| Affinis | 6535 | FDA UDI | Class II | Active |
| Alpen Diamond Instruments | R379C023FG | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200799AA | FDA UDI | Class I | Active |
| HyFlex™ Paper Points | 60022685 | FDA UDI | Class I | Active |
| DIATECH Diamond Instruments | 60019254 | FDA UDI | Class I | Active |
| Affinis | 6510 | FDA UDI | Class II | Unknown |
| Diatech Diamond Instruments | 200437DD | FDA UDI | Class I | Active |
| Alpen Diamond Instruments | R852F012FG | FDA UDI | Class I | Active |
| Miris2 | 8445 | FDA UDI | Class II | Active |
| Alpen Diamond Instruments | R879KTC021FG | FDA UDI | Class I | Active |
| HYGENIC® Paper Points | H02119 | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200714DD | FDA UDI | Class I | Active |
| Alpen Diamond Instruments | R859UF018FG | FDA UDI | Class I | Active |
| BRILLIANT EverGlow | 60019737 | FDA UDI | Class II | Unknown |
| Diatech Diamond Instruments | 200177AA | FDA UDI | Class I | Active |
| BRILLIANT Crios | 60020017 | FDA UDI | Class II | Active |
| Diatech Diamond Instruments | 200684DD | FDA UDI | Class I | Active |
| One Coat 7 Universal | 60019539 | FDA UDI | Class II | Active |
| Componeer | 1320 | FDA UDI | Class II | Active |
| HyFlex™ EDM | 60019631 | FDA UDI | Class I | Active |
| Speedex | 4986 | FDA UDI | Class II | Active |
| Brilliant Componeer | 60023132 | FDA UDI | Class II | Active |
| Diatech Diamond Instruments | 200449AA | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200619AA | FDA UDI | Class I | Active |
| TempoSIL 2 | 6728 | FDA UDI | Class II | Active |
| Miris2 | 8408 | FDA UDI | Class II | Active |
| Affinis | 6520 | FDA UDI | Class II | Active |
| Alpen Diamond Instruments | R807C012FG | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 205003DD | FDA UDI | Class I | Active |
| BRILLIANT EverGlow | 60021837 | FDA UDI | Class II | Active |
| Diatech Diamond Instruments | 200470AA | FDA UDI | Class I | Active |
| Diatech Diamond Instruments | 200122AA | FDA UDI | Class I | Active |
| HYGENIC® Paper Points | H03346 | FDA UDI | Class I | Active |
| Alpen Diamond Instruments | RS801F016FG | FDA UDI | Class I | Active |
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