Straumann® Anatomic Healing Abutments XC (AHA)
FDA 510(k) clearance K241575 · decided 2024-11-11
Clearance details
- K-number
- K241575
- Device name
- Straumann® Anatomic Healing Abutments XC (AHA)
- Applicant
- Straumann USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-06-03
- Decision date
- 2024-11-11
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. recall (Z-1671-2025) | Straumann USA LLC | 2025-04-24 |