PREFORMANCE POSTS
FDA 510(k) clearance K053170 · decided 2006-02-01
Clearance details
- K-number
- K053170
- Device name
- PREFORMANCE POSTS
- Applicant
- Implant Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2006-02-01
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants recall (Z-2414-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Preformance 15 degrees Pre-Angled Post Dental implants recall (Z-2491-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Preformance Post Dental implants recall (Z-2492-2016) | Biomet 3i, LLC | 2016-08-12 |