Cleared Traditional

K923556 - ADP FACEMASK

K923556 is an FDA 510(k) clearance for ADP FACEMASK, 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 140-day FDA review.

K923556 · Ormco Corp. · Dental device
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Dec 1992
Decision
140d
Days
Class 2
Risk

K923556 is an FDA 510(k) clearance for the ADP FACEMASK. 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 December 4, 1992 after a review of 140 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K923556

510(k) Number K923556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date December 04, 1992
Days to Decision 140 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
12d slower than avg
Panel avg: 128d · This submission: 140d
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 K923556.
NEW GEAR RELEASABLE HEADGEAR
K940410 · Ortho Kinetics Corp. · Mar 1994
SOFT-WEAR HEADGEAR AND SAFETY MODULES
K932761 · Professional Positioners, Inc. · Oct 1993
FACEBOW
K925240 · Forestadent Bernhard Forster GmbH · Jun 1993
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
K923556 · ADP FACEMASK
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