Cleared Traditional

THE GNATHOMETER (K033092) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033092 · Ortho Gnathics, LLC · Dental device
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Apr 2004
Decision
205d
Days
Class 2
Risk

K033092 is an FDA 510(k) clearance for the THE GNATHOMETER. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Ortho Gnathics, LLC (Pittsburgh, US). The FDA issued a Cleared decision on April 21, 2004 after a review of 205 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Ortho Gnathics, LLC devices

Submission Details

510(k) Number K033092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date April 21, 2004
Days to Decision 205 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
78d slower than avg
Panel avg: 127d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 90
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K033092.
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · Synthes (Usa) · Mar 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · Synthes (Usa) · Nov 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
K033121 · Synthes (Usa) · Oct 2003
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · Synthes (Usa) · Oct 2003