BIOHORIZONS ABUTMENTS FOR ZIMMER
FDA 510(k) clearance K103691 · decided 2011-11-03
Clearance details
- K-number
- K103691
- Device name
- BIOHORIZONS ABUTMENTS FOR ZIMMER
- Applicant
- BioHorizons Implant Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-17
- Decision date
- 2011-11-03
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch BioHorizons Implant Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Temporary Titanium Abutments recall (Z-1111-2025) | DDS Lab | 2025-02-05 |