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FDA 510(k)

ENAMEL PRO

K-Number: K062166 · 2006-11-21

ApplicantPremier Dental Products Co.
Decision Date2006-11-21
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENAMEL PRO 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 2006-11-21 under 510(k) number K062166. 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 ENAMEL PRO?

ENAMEL PRO is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Premier Dental Products Co.. The 510(k) number is K062166.

When did ENAMEL PRO receive FDA 510(k) clearance?

ENAMEL PRO received FDA 510(k) clearance on 2006-11-21, under 510(k) number K062166.

Who is the listed applicant for ENAMEL PRO?

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 ENAMEL PRO?

The FDA product code for ENAMEL PRO is EJR.

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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 PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK061997PREMIER SELF-ETCHING ENAMEL SEALANTK061998PREMIER SELF-ETCHING BOND ENHANCER

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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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