Custom Abutments
FDA 510(k) clearance K243278 · decided 2025-02-21
Clearance details
- K-number
- K243278
- Device name
- Custom Abutments
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2024-10-16
- Decision date
- 2025-02-21
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Basal, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; recall (Z-1633-2026) | Straumann USA LLC | 2026-03-24 |