Cleared Traditional

K091812 - FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS

K091812 is an FDA 510(k) clearance for FRONTIER DEVICES CRANIOMAXILLOFACIAL, manufactured by Frontier Devices, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K091812 · Frontier Devices, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
323d
Days
Class 2
Risk

K091812 is an FDA 510(k) clearance for the FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE .... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Frontier Devices, Inc. (Pelham, US). The FDA issued a Cleared decision on May 7, 2010 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Frontier Devices, Inc. devices

FDA 510(k) Submission Details - K091812

510(k) Number K091812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date May 07, 2010
Days to Decision 323 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 127d · This submission: 323d
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 230
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K091812.
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SUSTAIN SPACE MAINTENANCE SYSTEM
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MEDPOR FIXATION SYSTEM
K091807 · Porex Surgical, Inc. · Jun 2010
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
K091233 · Synthes (Usa) · Dec 2009
LEFORTE SYSTEM BONE PLATE
K091679 · Jeil Medical Corporation · Oct 2009
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
K091144 · Synthes (Usa) · Aug 2009