TAPERED SCREW-VENT X IMPLANT
FDA 510(k) clearance K112160 · decided 2011-12-14
Clearance details
- K-number
- K112160
- Device name
- TAPERED SCREW-VENT X IMPLANT
- Applicant
- Zimmer Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-27
- Decision date
- 2011-12-14
- Days to decision
- 140 days
- Clearance type
- Traditional
- 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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