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FDA 510(k)

DENTAL ENDODONTIC CEMENT

K-Number: K810026 · 1981-01-28

ApplicantWitech Laboratory
Decision Date1981-01-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ENDODONTIC CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Witech Laboratory. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K810026. 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 DENTAL ENDODONTIC CEMENT?

DENTAL ENDODONTIC CEMENT is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Witech Laboratory. The 510(k) number is K810026.

When did DENTAL ENDODONTIC CEMENT receive FDA 510(k) clearance?

DENTAL ENDODONTIC CEMENT received FDA 510(k) clearance on 1981-01-28, under 510(k) number K810026.

Who is the listed applicant for DENTAL ENDODONTIC CEMENT?

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

What is the FDA product code for DENTAL ENDODONTIC CEMENT?

The FDA product code for DENTAL ENDODONTIC CEMENT is EMA.

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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