PINK CAD/CAM disc— 510(k) K153546
Substantially EquivalentPolident D.O.O., Dental Products Industry
FDA 510(k) clearance K153546 for PINK CAD/CAM disc, Substantially Equivalent on 2016-09-28. Applicant: Polident D.O.O., Dental Products Industry. Device class: 2.
Clearance details
- Applicant
- Polident D.O.O., Dental Products Industry
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Volcja Draga, SI
Recent devices under product code EBI
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view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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