Cleared Traditional

K922499 - REFLECTIONS - CERAMIC DENTAL BRACKET

K922499 is an FDA 510(k) clearance for REFLECTIONS - CERAMIC DENTAL BRACKET, manufactured by Cdb Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K922499 · Cdb Corp. · Dental device
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Jul 1992
Decision
64d
Days
Class 1
Risk

K922499 is an FDA 510(k) clearance for the REFLECTIONS - CERAMIC DENTAL BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Cdb Corp. (Wilmington, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 - K922499

510(k) Number K922499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date July 30, 1992
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 88
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K922499.
GERMAN MINI DYNALOCK
K923432 · Unitek Corp. · Oct 1992
ORTHODONTIC STAINLESS STEEL BRACKET
K923029 · Gac Intl., Inc. · Sep 1992
GLENROE GOLDEN ORTHODONTIC BRACKET
K923124 · Glenroe · Aug 1992
ORTHODONTIC ELASTICS BANDS
K920645 · Masel Industries, Inc. · Jul 1992
MIDAS BRACKET
K914003 · Gold'N Braces, Inc. · Dec 1991
REFURBISHED ORTHODONTIC APPLIANCES
K913913 · Ortho-Cycle Co. · Nov 1991
K922499 · REFLECTIONS - CERAMIC DENTAL BRACKET
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