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FDA 510(k)

ALPHA-DENT COPAL CAVITY VARNISH

K-Number: K955521 · 1996-01-24

ApplicantWallace A. Erickson & Co.
Decision Date1996-01-24
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-DENT COPAL CAVITY VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Wallace A. Erickson & Co.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955521. 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 ALPHA-DENT COPAL CAVITY VARNISH?

ALPHA-DENT COPAL CAVITY VARNISH is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K955521.

When did ALPHA-DENT COPAL CAVITY VARNISH receive FDA 510(k) clearance?

ALPHA-DENT COPAL CAVITY VARNISH received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955521.

Who is the listed applicant for ALPHA-DENT COPAL CAVITY VARNISH?

The FDA 510(k) record lists Wallace A. Erickson & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA-DENT COPAL CAVITY VARNISH?

The FDA product code for ALPHA-DENT COPAL CAVITY VARNISH is LBH.

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Other records listing Wallace A. Erickson & Co. as applicant

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K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000K963922ALPHA-DENT ROOT CANAL SEALER & FILLERK960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEK960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)K960165ALPHA-DENT COMPOSITE SURFACE SEALANTK960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL

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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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