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FDA 510(k)

VOCO Profluorid Varnish + BioMin

K-Number: K252073 · 2026-05-01

ApplicantVoco GmbH
Decision Date2026-05-01
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VOCO Profluorid Varnish + BioMin is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252073. 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 VOCO Profluorid Varnish + BioMin?

VOCO Profluorid Varnish + BioMin is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Voco GmbH. The 510(k) number is K252073.

When did VOCO Profluorid Varnish + BioMin receive FDA 510(k) clearance?

VOCO Profluorid Varnish + BioMin received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252073.

Who is the listed applicant for VOCO Profluorid Varnish + BioMin?

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

What is the FDA product code for VOCO Profluorid Varnish + BioMin?

The FDA product code for VOCO Profluorid Varnish + BioMin is LBH.

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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.

K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLCK241489ReminGelInter-Med, 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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