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FDA 510(k)

PCXX VARNISH

K-Number: K113146 · 2012-01-23

ApplicantRoss Healthcare, Inc.
Decision Date2012-01-23
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PCXX VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Ross Healthcare, Inc.. It received FDA 510(k) clearance on 2012-01-23 under 510(k) number K113146. 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 PCXX VARNISH?

PCXX VARNISH is a medical device that received FDA 510(k) clearance on 2012-01-23. The listed applicant is Ross Healthcare, Inc.. The 510(k) number is K113146.

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

PCXX VARNISH received FDA 510(k) clearance on 2012-01-23, under 510(k) number K113146.

Who is the listed applicant for PCXX VARNISH?

The FDA 510(k) record lists Ross Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCXX VARNISH?

The FDA product code for PCXX VARNISH 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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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