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FDA 510(k)

ZINC PHOSPHATE CEMENT

K-Number: K003427 · 2001-01-24

ApplicantRite-Dent Manufacturing Corp.
Decision Date2001-01-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZINC PHOSPHATE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Rite-Dent Manufacturing Corp.. It received FDA 510(k) clearance on 2001-01-24 under 510(k) number K003427. 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 ZINC PHOSPHATE CEMENT?

ZINC PHOSPHATE CEMENT is a medical device that received FDA 510(k) clearance on 2001-01-24. The listed applicant is Rite-Dent Manufacturing Corp.. The 510(k) number is K003427.

When did ZINC PHOSPHATE CEMENT receive FDA 510(k) clearance?

ZINC PHOSPHATE CEMENT received FDA 510(k) clearance on 2001-01-24, under 510(k) number K003427.

Who is the listed applicant for ZINC PHOSPHATE CEMENT?

The FDA 510(k) record lists Rite-Dent Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZINC PHOSPHATE CEMENT?

The FDA product code for ZINC PHOSPHATE CEMENT is EMA.

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Other records listing Rite-Dent Manufacturing Corp. 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.

K020050ENAMEL BONDING SYSTEMK011822PIT AND FISSURE CHEMICAL CURING SEALANTK011453TOOTH SHADE RESIN MATERIALK010255CAVITY VARNISHK010240POLYCARBOXYLATE (PCA) CEMENTK003426ALGINATE IMPRESSION MATERIAL

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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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