Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
FDA 510(k) clearance K222836 · decided 2023-05-15
Clearance details
- K-number
- K222836
- Device name
- Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2022-09-20
- Decision date
- 2023-05-15
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant recall (Z-1995-2026) | Straumann USA LLC | 2026-04-29 |