Cleared Traditional

K902646 - HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP

K902646 is an FDA 510(k) clearance for HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH ..., manufactured by Ormco Corp.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K902646 · Ormco Corp. · Dental device
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Sep 1990
Decision
83d
Days
Class 2
Risk

K902646 is an FDA 510(k) clearance for the HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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 - K902646

510(k) Number K902646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1990
Decision Date September 06, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
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 - DZB Headgear, Extraoral, Orthodontic

All 29
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K902646.
ORTHODONTIC FACE BOW W/ INNER WIRE
K920784 · Gac Intl., Inc. · Mar 1992
ORTHODONTIC HEADGEAR
K912682 · K-Tek Orthodontic Products · Dec 1991
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K902645 · Ormco Corp. · Sep 1990
GUARDIAN SAFE BOW
K901958 · Lancer Orthodontics, Inc. · Jul 1990
SENTRY BREAKWAY NECK STRAP
K862538 · Ormco Corp. · Jul 1986
ADAPTABLE CLASS III MASK
K861424 · Great Lakes Orthodontics, Ltd. · May 1986
K902646 · HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
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