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FDA 510(k)

ACTIV VARNISH

K-Number: K112946 · 2011-12-09

ApplicantPulpdent Corporation
Decision Date2011-12-09
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACTIV VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2011-12-09 under 510(k) number K112946. 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 ACTIV VARNISH?

ACTIV VARNISH is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Pulpdent Corporation. The 510(k) number is K112946.

When did ACTIV VARNISH receive FDA 510(k) clearance?

ACTIV VARNISH received FDA 510(k) clearance on 2011-12-09, under 510(k) number K112946.

Who is the listed applicant for ACTIV VARNISH?

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 ACTIV VARNISH?

The FDA product code for ACTIV VARNISH is LBH.

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Other records listing Pulpdent Corporation 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.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPK153249Pulpdent Solo Flowable Composite with MCPK130223RMGI FILLK123265RMGI LOW VISCOSITY

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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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