Cleared Traditional

K110796 - SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE

K110796 is an FDA 510(k) clearance for SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE, manufactured by Biomers Products, LLC. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K110796 · Biomers Products, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
9d
Days
Class 2
Risk

K110796 is an FDA 510(k) clearance for the SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Biomers Products, LLC (Vancouver, Bc, CA). The FDA issued a Cleared decision on March 31, 2011 after a review of 9 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 - K110796

510(k) Number K110796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2011
Decision Date March 31, 2011
Days to Decision 9 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
119d faster than avg
Panel avg: 128d · This submission: 9d
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
WILLIAM SAMMONS

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 39
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K110796.
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K110796 · SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
Download PDF FDA Summary Biomers Products, LLC