Cleared Traditional

K060492 - AESCULAP CRANIOFACIAL PLATE AND SCREW

K060492 is the FDA 510(k) clearance for AESCULAP CRANIOFACIAL PLATE AND SCREW by Aesculap, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K060492 · Aesculap, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
42d
Days
Class 2
Risk

K060492 is an FDA 510(k) clearance for the AESCULAP CRANIOFACIAL PLATE AND SCREW. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 42 days - a notably fast clearance 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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K060492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2006
Decision Date April 07, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K060492.
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K050669 · Jeil Medical Corporation · May 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · Synthes (Usa) · May 2005