Cleared Traditional

K980195 - FACEBOW

K980195 is an FDA 510(k) clearance for FACEBOW, manufactured by Ortho Kinetics Corp.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K980195 · Ortho Kinetics Corp. · Dental device
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Mar 1998
Decision
50d
Days
Class 2
Risk

K980195 is an FDA 510(k) clearance for the FACEBOW. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Ortho Kinetics Corp. (Vista, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 50 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.

View all Ortho Kinetics Corp. devices

FDA 510(k) Submission Details - K980195

510(k) Number K980195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date March 11, 1998
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 9
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K980195.
CLASS III REVERSE PULL FACEMASK
K980436 · Ortho Kinetics Corp. · Apr 1998
NITOM LOCKING FACEBOW
K980245 · Ortho Kinetics Corp. · Apr 1998
RELEASABLE FORCE MODULE
K980151 · Ortho Kinetics Corp. · Apr 1998
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