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FDA 510(k)

PULPDENT COPAL VARNISH WITH FLUORIDE

K-Number: K100503 · 2010-05-12

ApplicantPulpdent Corporation
Decision Date2010-05-12
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT COPAL VARNISH WITH FLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K100503. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT COPAL VARNISH WITH FLUORIDE?

PULPDENT COPAL VARNISH WITH FLUORIDE is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Pulpdent Corporation. The 510(k) number is K100503.

When did PULPDENT COPAL VARNISH WITH FLUORIDE receive FDA 510(k) clearance?

PULPDENT COPAL VARNISH WITH FLUORIDE received FDA 510(k) clearance on 2010-05-12, under 510(k) number K100503.

Who is the listed applicant for PULPDENT COPAL VARNISH WITH FLUORIDE?

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

What is the FDA product code for PULPDENT COPAL VARNISH WITH FLUORIDE?

The FDA product code for PULPDENT COPAL VARNISH WITH FLUORIDE is LBH.

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Other records listing Pulpdent Corporation as applicant

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Related Devices (Code: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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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