QUICKBRIDGE TM CYLINDER AND CAP
FDA 510(k) clearance K071551 · decided 2007-08-30
Clearance details
- K-number
- K071551
- Device name
- QUICKBRIDGE TM CYLINDER AND CAP
- Applicant
- Biomet 3i, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-06
- Decision date
- 2007-08-30
- Days to decision
- 85 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 |
|---|---|---|
| Quickbridge TM Cap Dental implants recall (Z-2442-2016) | Biomet 3i, LLC | 2016-08-12 |