LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
FDA 510(k) clearance K083324 · decided 2009-02-25
Clearance details
- K-number
- K083324
- Device name
- LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
- Applicant
- Zest Anchors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-12
- Decision date
- 2009-02-25
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Escondido, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.