Cleared Traditional

K936151 - EXTRAORAL HEADGEAR

K936151 is an FDA 510(k) clearance for EXTRAORAL HEADGEAR, manufactured by Dentauraum, Inc.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K936151 · Dentauraum, Inc. · Dental device
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Aug 1994
Decision
217d
Days
Class 2
Risk

K936151 is an FDA 510(k) clearance for the EXTRAORAL HEADGEAR. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 217 days - an extended review 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: 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K936151

510(k) Number K936151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date August 01, 1994
Days to Decision 217 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
90d slower than avg
Panel avg: 127d · This submission: 217d
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

Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K936151.
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