TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
FDA 510(k) clearance K072589 · decided 2007-10-04
Clearance details
- K-number
- K072589
- Device name
- TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
- Applicant
- Zimmer Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-14
- Decision date
- 2007-10-04
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. recall (Z-1190-2018) | Zimmer Dental Inc | 2018-03-05 |
| Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered recall (Z-0154-2015) | Zimmer Dental Inc | 2014-10-30 |
| Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, L recall (Z-0847-2014) | Zimmer Dental Inc | 2014-01-28 |