Cleared Traditional

K081143 - BIOMERS TRANSLUCENT ORTHODONTIC WIRE

K081143 is an FDA 510(k) clearance for BIOMERS TRANSLUCENT ORTHODONTIC WIRE, manufactured by Biomers Product, LLC. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K081143 · Biomers Product, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K081143

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DYW Device Classification - Class 2, Special Controls

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

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 - DYW Bracket, Plastic, Orthodontic

All 40
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K081143.
CLEARARCH
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K082207 · Cadent, Inc. · Oct 2009
ELATION MB METAL REINFORCED PLASTIC BRACKET
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OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K071055 · Ultradent Products, Inc. · May 2007
LINGLOCK
K061042 · Sybron Dental Specialties · Jan 2007
EVERSTICK A&O
K051953 · Stick Tech , Ltd. · Mar 2006
K081143 · BIOMERS TRANSLUCENT ORTHODONTIC WIRE
Download PDF FDA Summary Biomers Product, LLC