3I LOCATER ABUTMENT SYSTEM
FDA 510(k) clearance K012911 · decided 2001-09-28
Clearance details
- K-number
- K012911
- Device name
- 3I LOCATER ABUTMENT SYSTEM
- Applicant
- Implant Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-30
- Decision date
- 2001-09-28
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- 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 |
|---|---|---|
| Locator Extended Range Males 4pk Dental implants recall (Z-2427-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Extra Light Angled Replacement Males 4pk Dental implants recall (Z-2428-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Extra Light Retention Males 4pk Dental implants recall (Z-2429-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Light Retention Replacement Males 4pk Dental implants recall (Z-2430-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Replacement Housing Dental implants recall (Z-2431-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Replacement Housing Kit Dental implants recall (Z-2432-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Replacement Males 4pk Dental implants recall (Z-2433-2016) | Biomet 3i, LLC | 2016-08-12 |
| Locator Abutment Dental implants recall (Z-2480-2016) | Biomet 3i, LLC | 2016-08-12 |
| Certain Locator Abutment Dental implants recall (Z-2487-2016) | Biomet 3i, LLC | 2016-08-12 |
| LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2 recall (Z-0810-2010) | Biomet 3i, LLC | 2010-02-22 |