Cleared Traditional

K061507 - SONICWELD RX ENDOBROW FIXATION

K061507 is the FDA 510(k) clearance for SONICWELD RX ENDOBROW FIXATION by KLS-Martin L.P.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K061507 · KLS-Martin L.P. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
112d
Days
Class 2
Risk

K061507 is an FDA 510(k) clearance for the SONICWELD RX ENDOBROW FIXATION. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on September 21, 2006 after a review of 112 days - within the typical 510(k) review window.

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 KLS-Martin L.P. devices

Submission Details

510(k) Number K061507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2006
Decision Date September 21, 2006
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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 K061507.
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
K063052 · Walter Lorenz Surgical, Inc. · Jan 2007
KLS MARTIN RIGID FIXATION - STERILE
K060177 · KLS-Martin L.P. · Apr 2006
AESCULAP CRANIOFACIAL PLATE AND SCREW
K060492 · Aesculap, Inc. · Apr 2006
RESORB-X SF
K051236 · KLS-Martin L.P. · Aug 2005