KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
FDA 510(k) clearance K151194 · decided 2016-01-29
Clearance details
- K-number
- K151194
- Device name
- KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
- Applicant
- SOADCO, S.L.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-04
- Decision date
- 2016-01-29
- Days to decision
- 270 days
- Clearance type
- Abbreviated
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Escaldes-Engordany, AD
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.