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FDA 510(k)

PMMA CAD/CAM DISC

K-Number: K112967 · 2012-08-28

ApplicantPolident D.O.O., Dental Products Industry
Decision Date2012-08-28
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PMMA 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 2012-08-28 under 510(k) number K112967. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMMA CAD/CAM DISC?

PMMA CAD/CAM DISC is a medical device that received FDA 510(k) clearance on 2012-08-28. The listed applicant is Polident D.O.O., Dental Products Industry. The 510(k) number is K112967.

When did PMMA CAD/CAM DISC receive FDA 510(k) clearance?

PMMA CAD/CAM DISC received FDA 510(k) clearance on 2012-08-28, under 510(k) number K112967.

Who is the listed applicant for PMMA 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 PMMA CAD/CAM DISC?

The FDA product code for PMMA CAD/CAM DISC is EBG.

Other records listing Polident D.O.O., Dental Products Industry as applicant

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.

K153546PINK CAD/CAM disc

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

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