Cleared Traditional

K202276 - BracePaste Band and Build LC

K202276 is the FDA 510(k) clearance for BracePaste Band and Build LC by American Orthodontics. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K202276 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
3d
Days
Class 2
Risk

K202276 is an FDA 510(k) clearance for the BracePaste Band and Build LC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 14, 2020 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Orthodontics devices

Submission Details

510(k) Number K202276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2020
Decision Date August 14, 2020
Days to Decision 3 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 127d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 Consultant

Accelerated Device Approval Services
Rafael Aguila

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 81
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K202276.
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K214054 · Tp Orthodontics, Inc. · Oct 2022
FiteBac CC OrthoSeal
K210115 · Largent Health, LLC · Jul 2021
Orthocem, Ortho Bite
K192682 · Dentscare Ltda · Aug 2020
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388 · Reliance Orthodontic Products, Inc. · Apr 2020
BrackFix
K183147 · Voco GmbH · Mar 2019
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020 · Pulpdent Corporation · Jan 2018