ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
FDA 510(k) clearance K112730 · decided 2012-01-13
Clearance details
- K-number
- K112730
- Device name
- ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
- Applicant
- Biomet 3i
- Decision
- Substantially Equivalent
- Date received
- 2011-09-20
- Decision date
- 2012-01-13
- Days to decision
- 115 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 |
|---|---|---|
| LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants recall (Z-2422-2016) | Biomet 3i, LLC | 2016-08-12 |
| LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants recall (Z-2423-2016) | Biomet 3i, LLC | 2016-08-12 |