Cleared Traditional

K932761 - SOFT-WEAR HEADGEAR AND SAFETY MODULES

K932761 is an FDA 510(k) clearance for SOFT-WEAR HEADGEAR AND SAFETY MODULES, manufactured by Professional Positioners, Inc.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K932761 · Professional Positioners, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
121d
Days
Class 2
Risk

K932761 is an FDA 510(k) clearance for the SOFT-WEAR HEADGEAR AND SAFETY MODULES. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Professional Positioners, Inc. (Racine, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 121 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.

View all Professional Positioners, Inc. devices

FDA 510(k) Submission Details - K932761

510(k) Number K932761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date October 07, 1993
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
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 19
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K932761.
SAFETY RELEASE MODULE
K961754 · G & H Wire Co. · Jul 1996
CLP BONNET
K955528 · Clp Products · Feb 1996
EXTRAORAL HEADGEAR
K936151 · Dentauraum, Inc. · Aug 1994
ADP FACEMASK
K923556 · Ormco Corp. · Dec 1992
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K902645 · Ormco Corp. · Sep 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
K902646 · Ormco Corp. · Sep 1990