Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
FDA 510(k) clearance K180564 · decided 2019-01-07
Clearance details
- K-number
- K180564
- Device name
- Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
- Applicant
- Medentika GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-03-05
- Decision date
- 2019-01-07
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Huegelsheim, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.