KDG Abutments
FDA 510(k) clearance K221381 · decided 2022-08-10
Clearance details
- K-number
- K221381
- Device name
- KDG Abutments
- Applicant
- Keystone Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-13
- Decision date
- 2022-08-10
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- 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.