FDA 510(k)

KETAC-CEM IN REF. TO K802048

K-Number: K802819 · 1980-11-24

Decision Date1980-11-24

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

KETAC-CEM IN REF. TO K802048 is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental Products. It received FDA 510(k) clearance on 1980-11-24 under 510(k) number K802819. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETAC-CEM IN REF. TO K802048?

KETAC-CEM IN REF. TO K802048 is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Espe Dental Products. The 510(k) number is K802819.

When did KETAC-CEM IN REF. TO K802048 receive FDA 510(k) clearance?

KETAC-CEM IN REF. TO K802048 received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802819.

Who is the listed applicant for KETAC-CEM IN REF. TO K802048?

The FDA 510(k) record lists Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KETAC-CEM IN REF. TO K802048?

The FDA product code for KETAC-CEM IN REF. TO K802048 is EMA.

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Other records listing Espe Dental Products as applicant

K810950VISIO-SEAL K802049NIMETIC-DISPERS K800031PERMADYNE POLYETHER RUBBER IMPRESSION K771901CAPMIX K771889UNIOLITE K771120IMPREFLEX ALGINATE IMPRESSION MATERIAL

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Related Devices (Code: EMA)

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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.