Cleared Traditional

K181965 - Restore Toothpaste

K181965 is the FDA 510(k) clearance for Restore Toothpaste by Dr. Collins, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 70
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
Clinpro Varnish
K151302 · 3M Company · Sep 2015
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013