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FDA 510(k)

FluoroCal

K-Number: K182917 · 2019-11-18

ApplicantBisco, Inc.
Decision Date2019-11-18
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FluoroCal is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K182917. 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 FluoroCal?

FluoroCal is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Bisco, Inc.. The 510(k) number is K182917.

When did FluoroCal receive FDA 510(k) clearance?

FluoroCal received FDA 510(k) clearance on 2019-11-18, under 510(k) number K182917.

Who is the listed applicant for FluoroCal?

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

What is the FDA product code for FluoroCal?

The FDA product code for FluoroCal is LBH.

Other records listing Bisco, Inc. 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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