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FDA 510(k)

RENAMELIZE POLISHING PASTE

K-Number: K862912 · 1986-08-12

ApplicantCosmedent, Inc.
Decision Date1986-08-12
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RENAMELIZE POLISHING PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K862912. 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 RENAMELIZE POLISHING PASTE?

RENAMELIZE POLISHING PASTE is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Cosmedent, Inc.. The 510(k) number is K862912.

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

RENAMELIZE POLISHING PASTE received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862912.

Who is the listed applicant for RENAMELIZE POLISHING PASTE?

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

What is the FDA product code for RENAMELIZE POLISHING PASTE?

The FDA product code for RENAMELIZE POLISHING PASTE is EJR.

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Other records listing Cosmedent, Inc. as applicant

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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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