Nobelprocera Ti Abutment Thommen Platforms
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101714 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nobelprocera Ti Abutment Thommen Platforms is an endosseous dental implant abutment that attaches directly to Thommen dental implants, providing a platform for restoration. It is designed and made individually to fit the individual requirements for each patient. The abutment is made of titanium and allows for customization and restorative flexibility with angulated screw channel solutions.
The Nobelprocera Ti Abutment Thommen Platforms is supplied by Nobel Biocare AB and has received FDA 510(k) authorization. The device is intended for use in dental implant restorations and is designed to be used with Thommen dental implants. The abutments are customized for each patient and are available in various configurations to accommodate individual needs.
Frequently asked questions
What is the Nobelprocera Ti Abutment Thommen Platforms used for?
The Nobelprocera Ti Abutment Thommen Platforms is used for dental implant restorations, providing a platform for restoration and attaching directly to Thommen dental implants.
What material is the abutment made of?
The abutment is made of titanium, allowing for customization and restorative flexibility with angulated screw channel solutions.
Is the Nobelprocera Ti Abutment Thommen Platforms customized for each patient?
Yes, the abutments are customized for each patient and are available in various configurations to accommodate individual needs.
What is the regulatory status of the Nobelprocera Ti Abutment Thommen Platforms?
The device has received FDA 510(k) authorization, indicating that it is substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS (K101714) — FDA 510 (k ..., Customized abutments & implant crowns | Procera - Nobel Biocare, PDF 1.4 510O(k) Summary of Safety and Effectiveness
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101714 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
Sources (1)
- FDA 510(k) K101714 24 fields · synced Oct 6, 2026