FDA 510(k)

BioMin Restore Plus

K-Number: K200077 · 2020-11-06

Decision Date2020-11-06

Product CodeLBH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BioMin Restore Plus is a medical device manufactured by Dr. Collins, Inc.. It received FDA 510(k) clearance on 2020-11-06 under approval 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. It is manufactured by Dr. Collins, Inc.. The 510(k) number is K200077.

When was BioMin Restore Plus approved by the FDA?

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

What company makes BioMin Restore Plus?

BioMin Restore Plus is manufactured by Dr. Collins, Inc..

What is the FDA product code for BioMin Restore Plus?

The FDA product code for BioMin Restore Plus is LBH.

Other Devices by Dr. Collins, Inc.

K181965Restore Toothpaste

Related Devices (Code: LBH)

K160377V-varnish PremiumVericom Co., Ltd. K153334Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC K182917FluoroCalBisco, Inc. K181965Restore ToothpasteDr. Collins, Inc. K200614FiteBac Antimicrobial Cavity CleanserLargent Health, LLC K192381DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow FlavorScientific Pharmaceuticals

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.