Cleared Traditional

K181965 - Restore Toothpaste

K181965 is an FDA 510(k) clearance for Restore Toothpaste, manufactured by Dr. Collins, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K181965 · Dr. Collins, Inc. · Dental device
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Jun 2019
Decision
325d
Days
Class 2
Risk

K181965 is an FDA 510(k) clearance for the Restore Toothpaste. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Dr. Collins, Inc. (Irvine, US). The FDA issued a Cleared decision on June 13, 2019 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dr. Collins, Inc. devices

FDA 510(k) Submission Details - K181965

510(k) Number K181965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date June 13, 2019
Days to Decision 325 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 127d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K181965.
Cervitec F
K191453 · Ivoclar Vivadent, AG · Feb 2020
FiteBac Cavity Cleanser
K190271 · Largent Health, LLC · Jan 2020
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Oral-B 5% Sodium Fluoride Varnish
K153334 · Young Dental Manufacturing Co. 1, LLC · May 2016
Clinpro Varnish
K151302 · 3M Company · Sep 2015