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Sign in to claim this brandWhat Nobel Biocare AG makes
Nobel Biocare AG manufactures dental implant suprastructures, including permanent, temporary single-use, and reusable preformed types, as well as reusable surgical screwdrivers and dental drill bits. Their portfolio also includes dental prosthesis/implant abutment screws and ceramic dental bridges designed for multi-unit applications.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Nobel Biocare AG primarily manufacture?
Nobel Biocare AG specializes in dental implant-related devices, including permanent and temporary preformed suprastructures (both single-use and reusable), reusable surgical screwdrivers, and dental drill bits. Their portfolio also covers dental prosthesis/implant abutment screws and ceramic dental bridges designed for multi-unit applications, such as full-arch restorations.
Where is Nobel Biocare AG based, and does this affect its regulatory standing?
Nobel Biocare AG is based in the United States. While the company’s headquarters location is relevant for regulatory oversight and compliance (e.g., FDA jurisdiction), it does not inherently determine whether its devices are authorized—only individual devices undergo evaluation and classification by regulatory bodies like the FDA.
Which regulatory registries list Nobel Biocare AG’s devices, and why is this important?
Nobel Biocare AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides standardized identification for medical devices, ensuring traceability, reducing medical errors, and supporting regulatory compliance. Listing in the UDI database helps healthcare providers and regulators verify device details, such as manufacturer information and classification.
How are Nobel Biocare AG’s devices classified under FDA regulations, and what does this mean?
Nobel Biocare AG’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls (e.g., labeling, manufacturing practices), while Class II devices involve moderate risk and may require additional controls like special labeling or performance standards. Classification determines the regulatory scrutiny and compliance requirements each device must meet.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (2875)
Page 58 of 58| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Procera Esthetic Abutment | 33790 | FDA UDI | Class II | Unknown |
| Procera Esthetic Abutment | 33764 | FDA UDI | Class II | Unknown |
| Snappy™ | 37840 | FDA UDI | Class II | Active |
| On1™ | 38695 | FDA UDI | Class II | Active |
| creos™ syntoprotect | N1615TI-A10-1 | FDA UDI | Class II | Unknown |
| NobelPro Line™ | 32333 | FDA UDI | Class II | Active |
| On1™ | 38733 | FDA UDI | Class I | Active |
| Snappy™ | 35975 | FDA UDI | Class II | Active |
| Procera Esthetic Abutment | 33768 | FDA UDI | Class II | Unknown |
| On1™ | 38694 | FDA UDI | Class II | Active |
| Procera Esthetic Abutment | 36629 | FDA UDI | Class II | Unknown |
| Snappy™ | 35850 | FDA UDI | Class II | Active |
| DTX Studio™ Clinic | 3.3_L | FDA UDI | Class II | Unknown |
| Narrow Profile Abutment | 36679 | FDA UDI | Class II | Unknown |
| NobelPro Line™ | 32330 | FDA UDI | Class II | Active |
| Snappy Abutment | 32345 | FDA UDI | Class II | Unknown |
| creos™ syntoprotect | N1625TI-A07-1 | FDA UDI | Class II | Unknown |
| Procera Esthetic Abutment | 33761 | FDA UDI | Class II | Unknown |
| creos™ syntoprotect | N1625TI-A06-1 | FDA UDI | Class II | Unknown |
| On1™ | 38726 | FDA UDI | Class I | Unknown |
| NobelPro Line™ | 37774 | FDA UDI | Class II | Active |
| DTX Studio™ Clinic | 1.8 | FDA UDI | Class II | Active |
| Procera Esthetic Abutment | 33778 | FDA UDI | Class II | Unknown |
| Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | K212125 | FDA 510(k) | Class II | Active |
| Universal Base Conical Connection (CC) | K200040 | FDA 510(k) | Class II | Active |
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