LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
FDA 510(k) clearance K092341 · decided 2009-11-30
Clearance details
- K-number
- K092341
- Device name
- LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
- Applicant
- Biomet 3i, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-04
- Decision date
- 2009-11-30
- Days to decision
- 118 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 |
|---|---|---|
| EP Healing Abutment Dental implants recall (Z-2463-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: recall (Z-1456-2012) | Biomet 3i, LLC | 2012-04-25 |
| LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders a recall (Z-2884-2011) | Biomet 3i, LLC | 2011-07-26 |