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FDA 510(k)

NIMETIC POLISHING PASTE

K-Number: K812118 · 1981-08-31

ApplicantEspe-Premier Sales Co.
Decision Date1981-08-31
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NIMETIC POLISHING PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Espe-Premier Sales Co.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812118. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIMETIC POLISHING PASTE?

NIMETIC POLISHING PASTE is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Espe-Premier Sales Co.. The 510(k) number is K812118.

When did NIMETIC POLISHING PASTE receive FDA 510(k) clearance?

NIMETIC POLISHING PASTE received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812118.

Who is the listed applicant for NIMETIC POLISHING PASTE?

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

What is the FDA product code for NIMETIC POLISHING PASTE?

The FDA product code for NIMETIC POLISHING PASTE is EJR.

Related Clinical Trials

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.

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Other records listing Espe-Premier Sales 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.

K812116PERMAGUMK812117PERMAGUM ADHESIVEK812119NIMETIC-DISPERSK812115KETAC-CHEMK811624VISIO-SEALK810265VISIO-BAND

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Related Devices (Code: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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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