Cleared Traditional

K944286 - METAL-LINED TRANSCEND CERAMIC BRACKET

K944286 is the FDA 510(k) clearance for METAL-LINED TRANSCEND CERAMIC BRACKET by Unitek Corp.. It is a Class 2 Dental device (product code DYW) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K944286 · Unitek Corp. · Dental device
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Nov 1994
Decision
88d
Days
Class 2
Risk

K944286 is an FDA 510(k) clearance for the METAL-LINED TRANSCEND CERAMIC BRACKET. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on November 29, 1994 after a review of 88 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 Unitek Corp. devices

Submission Details

510(k) Number K944286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1994
Decision Date November 29, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 21
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K944286.
DAMON FT
K032408 · Sybron Dental Specialties, Inc. · Oct 2003
SPIRIT MB
K955333 · Ormco Corp. · Jan 1996
GLOWING SPIRITS
K951239 · Ormco Corp. · Jul 1995
SPIRIT MB
K943245 · Sybron Dental Specialties, Inc. · Aug 1994
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
K900809 · Lee Pharmaceuticals · Jun 1990
SPIRIT
K896913 · Ormco Corp. · Mar 1990