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FDA 510(k)

TYPE 1 DENTAL CEMENT

K-Number: K921173 · 1992-11-04

ApplicantCentrix, Inc.
Decision Date1992-11-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TYPE 1 DENTAL CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K921173. 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 TYPE 1 DENTAL CEMENT?

TYPE 1 DENTAL CEMENT is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Centrix, Inc.. The 510(k) number is K921173.

When did TYPE 1 DENTAL CEMENT receive FDA 510(k) clearance?

TYPE 1 DENTAL CEMENT received FDA 510(k) clearance on 1992-11-04, under 510(k) number K921173.

Who is the listed applicant for TYPE 1 DENTAL CEMENT?

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

What is the FDA product code for TYPE 1 DENTAL CEMENT?

The FDA product code for TYPE 1 DENTAL CEMENT is EMA.

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Other records listing Centrix, Inc. 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.

K250714FluoroDose VarnishK222459Centrix FluoroSilver Silver Diamine Fluoride 38%K152826NoCordK120176SENZZZZZ AWAYK111348RE / STASIS (TM) GINGIVAL RETRACTION PASTEK092384LIQUICORD

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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

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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