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 the device name listed in this FDA 510(k) record. The listed applicant is Polident D.O.O., Dental Products Industry. It received FDA 510(k) clearance on 2016-09-28 under 510(k) 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. The listed applicant is Polident D.O.O., Dental Products Industry. The 510(k) number is K153546.

When did PINK CAD/CAM disc receive FDA 510(k) clearance?

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

Who is the listed applicant for PINK CAD/CAM disc?

The FDA 510(k) record lists Polident D.O.O., Dental Products Industry as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

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