Cleared Traditional

K033092 - THE GNATHOMETER

K033092 is an FDA 510(k) clearance for THE GNATHOMETER, manufactured by Ortho Gnathics, LLC. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 205-day FDA review.

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

FDA 510(k) Submission Details - K033092

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.

JEY Device Classification - Class 2, Special Controls

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 246
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K033092.
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LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · Walter Lorenz Surgical, Inc. · May 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · Inion , Ltd. · Oct 2003
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
K033121 · Synthes (Usa) · Oct 2003