Cleared Traditional

K942826 - ORTHODONITC METAL REINFORCED PLASTIC BRACKET

K942826 is an FDA 510(k) clearance for ORTHODONITC METAL REINFORCED PLASTIC BR..., manufactured by Gac Intl., Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K942826 · Gac Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
183d
Days
Class 2
Risk

K942826 is an FDA 510(k) clearance for the ORTHODONITC METAL REINFORCED PLASTIC BRACKET. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on December 14, 1994 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Gac Intl., Inc. devices

FDA 510(k) Submission Details - K942826

510(k) Number K942826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1994
Decision Date December 14, 1994
Days to Decision 183 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
56d slower than avg
Panel avg: 127d · This submission: 183d
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 38
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K942826.
REFLECTIONS
K973776 · Cdb Corp. · Nov 1997
SPIRIT MB
K955333 · Ormco Corp. · Jan 1996
GLOWING SPIRITS
K951239 · Ormco Corp. · Jul 1995
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · Unitek Corp. · Nov 1994
SPIRIT MB
K943245 · Sybron Dental Specialties, Inc. · Aug 1994
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
K900809 · Lee Pharmaceuticals · Jun 1990