Cleared Traditional

K200077 - BioMin Restore Plus

K200077 is an FDA 510(k) clearance for BioMin Restore Plus, 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 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

FDA 510(k) Submission Details - K200077

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.

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 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