CONICAL ANGLED ABUTMENT
FDA 510(k) clearance K063403 · decided 2007-03-20
Clearance details
- K-number
- K063403
- Device name
- CONICAL ANGLED ABUTMENT
- Applicant
- Implant Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-09
- Decision date
- 2007-03-20
- Days to decision
- 131 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 |
|---|---|---|
| Conical 17 degree Angled Abutment Dental implants recall (Z-2504-2016) | Biomet 3i, LLC | 2016-08-12 |
| Conical 25 degree Angled Abutment Dental implants recall (Z-2505-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Conical 17 degree Angled Abutment Dental implants recall (Z-2513-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Conical 25 degree Angled Abutment Dental implants recall (Z-2514-2016) | Biomet 3i, LLC | 2016-08-12 |
| "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conica recall (Z-0158-2012) | Biomet 3i, LLC | 2011-11-03 |