Cleared Traditional

K200077 - BioMin Restore Plus

K200077 is the FDA 510(k) clearance for BioMin Restore Plus by Dr. Collins, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K200077 · Dr. Collins, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
297d
Days
Class 2
Risk

K200077 is an FDA 510(k) clearance for the BioMin Restore Plus. 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 November 6, 2020 after a review of 297 days - an extended review cycle.

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. Standard predicate reliance. 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 K200077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2020
Decision Date November 06, 2020
Days to Decision 297 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 127d · This submission: 297d
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 K200077.
Dental Desensitizer
K222891 · Guangzhou Beogene Biotech Co., Ltd. · May 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · 3M Espe Dental Products · May 2023
Apapro Desensitizer
K220419 · Sangi Co, Ltd. · Feb 2022
FiteBac Antimicrobial Cavity Cleanser
K200614 · Largent Health, LLC · Jun 2020
DFV 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 Flavor
K192381 · Scientific Pharmaceuticals · Feb 2020
Cervitec F
K191453 · Ivoclar Vivadent, AG · Feb 2020