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FDA 510(k)

V-varnish Premium

K-Number: K160377 · 2016-12-02

ApplicantVericom Co., Ltd.
Decision Date2016-12-02
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

V-varnish Premium is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K160377. 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 V-varnish Premium?

V-varnish Premium is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K160377.

When did V-varnish Premium receive FDA 510(k) clearance?

V-varnish Premium received FDA 510(k) clearance on 2016-12-02, under 510(k) number K160377.

Who is the listed applicant for V-varnish Premium?

The FDA 510(k) record lists Vericom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V-varnish Premium?

The FDA product code for V-varnish Premium is LBH.

Other records listing Vericom Co., Ltd. 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.

K253052Fluoride 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.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC

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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