PREFORMANCE TEMPORARY CYLINDER
FDA 510(k) clearance K060291 · decided 2006-02-27
Clearance details
- K-number
- K060291
- Device name
- PREFORMANCE TEMPORARY CYLINDER
- Applicant
- Implant Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-06
- Decision date
- 2006-02-27
- Days to decision
- 21 days
- Clearance type
- Special
- 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 5mm(P) Item: IIIC12 Dental implants recall (Z-2415-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Preformance Temporary Cylinder Dental implants recall (Z-2493-2016) | Biomet 3i, LLC | 2016-08-12 |
| Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant recall (Z-0128-2008) | Biomet 3i | 2008-01-17 |