Prima Plus Conical Implant System
FDA 510(k) clearance K240966 · decided 2024-07-09
Clearance details
- K-number
- K240966
- Device name
- Prima Plus Conical Implant System
- Applicant
- Keystone Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-09
- Decision date
- 2024-07-09
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.