Cleared Traditional

K981433 - ORTHODONTIC BRACES

K981433 is an FDA 510(k) clearance for ORTHODONTIC BRACES, manufactured by Midwest Orthodontic Mfg.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K981433 · Midwest Orthodontic Mfg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
66d
Days
Class 2
Risk

K981433 is an FDA 510(k) clearance for the ORTHODONTIC BRACES. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Midwest Orthodontic Mfg. (Columbus, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 66 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 Midwest Orthodontic Mfg. devices

FDA 510(k) Submission Details - K981433

510(k) Number K981433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date June 25, 1998
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DYW Bracket, Plastic, Orthodontic

All 25
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K981433.
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REFLECTIONS
K973776 · Cdb Corp. · Nov 1997
SPIRIT MB
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GLOWING SPIRITS
K951239 · Ormco Corp. · Jul 1995