PINK CAD/CAM disc
FDA 510(k) clearance K153546 · decided 2016-09-28
Clearance details
- K-number
- K153546
- Device name
- PINK CAD/CAM disc
- Applicant
- Polident D.O.O., Dental Products Industry
- Decision
- Substantially Equivalent
- Date received
- 2015-12-11
- Decision date
- 2016-09-28
- Days to decision
- 292 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Volcja Draga, SI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.