Cleared Traditional

BIOMERS TRANSLUCENT ORTHODONTIC WIRE (K081143) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081143 · Biomers Product, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
10d
Days
Class 2
Risk

K081143 is an FDA 510(k) clearance for the BIOMERS TRANSLUCENT ORTHODONTIC WIRE. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Biomers Product, LLC (Naples, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Biomers Product, LLC devices

Submission Details

510(k) Number K081143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2008
Decision Date May 02, 2008
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
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 - DYW Bracket, Plastic, Orthodontic

All 41
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K081143.
Carriere® Motion Pro® Clear Bite Corrector
K252760 · Ortho Organizers, Inc. · Nov 2025
Composite Orthodontic Brackets and Buttons
K251196 · Ec Certification Service GmbH · Apr 2025
Braces on Demand Bracket
K201940 · Braces on Demand, Inc. · Dec 2020
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018