OVERDENTURE ATTACHMENT
FDA 510(k) clearance K891613 · decided 1989-10-10
Clearance details
- K-number
- K891613
- Device name
- OVERDENTURE ATTACHMENT
- Applicant
- Implant Innovations International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-20
- Decision date
- 1989-10-10
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Palm Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants recall (Z-2424-2016) | Biomet 3i, LLC | 2016-08-12 |
| O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants recall (Z-2425-2016) | Biomet 3i, LLC | 2016-08-12 |
| O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants recall (Z-2426-2016) | Biomet 3i, LLC | 2016-08-12 |
| DAL-RO Housing, Female Assembly Dental implants recall (Z-2459-2016) | Biomet 3i, LLC | 2016-08-12 |
| DAL-RO Abutment Dental implants recall (Z-2460-2016) | Biomet 3i, LLC | 2016-08-12 |
| DAL-RO Threaded Female Dental implants recall (Z-2461-2016) | Biomet 3i, LLC | 2016-08-12 |