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FDA 510(k)

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT

K-Number: K042215 · 2004-09-21

ApplicantPremier Dental Products Co.
Decision Date2004-09-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2004-09-21 under 510(k) number K042215. 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 RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT?

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT is a medical device that received FDA 510(k) clearance on 2004-09-21. The listed applicant is Premier Dental Products Co.. The 510(k) number is K042215.

When did RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT receive FDA 510(k) clearance?

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT received FDA 510(k) clearance on 2004-09-21, under 510(k) number K042215.

Who is the listed applicant for RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT?

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

What is the FDA product code for RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT?

The FDA product code for RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT is EMA.

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Other records listing Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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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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