FDA 510(k)

Restore Toothpaste

K-Number: K181965 · 2019-06-13

Decision Date2019-06-13

Product CodeLBH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Restore Toothpaste is a medical device manufactured by Dr. Collins, Inc.. It received FDA 510(k) clearance on 2019-06-13 under approval number K181965. 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 Restore Toothpaste?

Restore Toothpaste is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Dr. Collins, Inc.. The 510(k) number is K181965.

When was Restore Toothpaste approved by the FDA?

Restore Toothpaste received FDA 510(k) clearance on 2019-06-13, under approval number K181965.

What company makes Restore Toothpaste?

Restore Toothpaste is manufactured by Dr. Collins, Inc..

What is the FDA product code for Restore Toothpaste?

The FDA product code for Restore Toothpaste is LBH.

Other Devices by Dr. Collins, Inc.

K200077BioMin Restore Plus

Related Devices (Code: LBH)

K160377V-varnish PremiumVericom Co., Ltd. K153334Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC K182917FluoroCalBisco, Inc. K200077BioMin Restore PlusDr. 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.