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FDA 510(k)

PINK CAD/CAM disc

K-Number: K153546 · 2016-09-28

ApplicantPolident D.O.O., Dental Products Industry
Decision Date2016-09-28
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PINK CAD/CAM disc is a medical device manufactured by Polident D.O.O., Dental Products Industry. It received FDA 510(k) clearance on 2016-09-28 under approval number K153546. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINK CAD/CAM disc?

PINK CAD/CAM disc is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Polident D.O.O., Dental Products Industry. The 510(k) number is K153546.

When was PINK CAD/CAM disc approved by the FDA?

PINK CAD/CAM disc received FDA 510(k) clearance on 2016-09-28, under approval number K153546.

What company makes PINK CAD/CAM disc?

PINK CAD/CAM disc is manufactured by Polident D.O.O., Dental Products Industry.

What is the FDA product code for PINK CAD/CAM disc?

The FDA product code for PINK CAD/CAM disc is EBI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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