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FDA 510(k)

BioMin Restore Plus

K-Number: K200077 · 2020-11-06

ApplicantDr. Collins, Inc.
Decision Date2020-11-06
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioMin Restore Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Collins, Inc.. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200077. 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 BioMin Restore Plus?

BioMin Restore Plus is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Dr. Collins, Inc.. The 510(k) number is K200077.

When did BioMin Restore Plus receive FDA 510(k) clearance?

BioMin Restore Plus received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200077.

Who is the listed applicant for BioMin Restore Plus?

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

What is the FDA product code for BioMin Restore Plus?

The FDA product code for BioMin Restore Plus is LBH.

Other records listing Dr. Collins, Inc. as applicant

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.

K181965Restore Toothpaste

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

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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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