Cleared Traditional

K925240 - FACEBOW

K925240 is an FDA 510(k) clearance for FACEBOW, manufactured by Forestadent Bernhard Forster GmbH. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K925240 · Forestadent Bernhard Forster GmbH · Dental device
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Jun 1993
Decision
245d
Days
Class 2
Risk

K925240 is an FDA 510(k) clearance for the FACEBOW. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Forestadent Bernhard Forster GmbH (D-7530 Pforzheim Germany, GR). The FDA issued a Cleared decision on June 18, 1993 after a review of 245 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.

FDA 510(k) Submission Details - K925240

510(k) Number K925240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date June 18, 1993
Days to Decision 245 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
117d slower than avg
Panel avg: 128d · This submission: 245d
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 K925240.
EXTRAORAL HEADGEAR
K936151 · Dentauraum, Inc. · Aug 1994
NEW GEAR RELEASABLE HEADGEAR
K940410 · Ortho Kinetics Corp. · Mar 1994
SOFT-WEAR HEADGEAR AND SAFETY MODULES
K932761 · Professional Positioners, Inc. · Oct 1993
ADP FACEMASK
K923556 · Ormco Corp. · Dec 1992
ORTHODONTIC FACE BOW W/ INNER WIRE
K920784 · Gac Intl., Inc. · Mar 1992
ORTHODONTIC HEADGEAR
K912682 · K-Tek Orthodontic Products · Dec 1991
K925240 · FACEBOW
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