Cleared Traditional

K950045 - KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM

K950045 is an FDA 510(k) clearance for KLS-MARTIN MANDIBULAR FRACTURE/RECONSTR..., manufactured by Karl Leibinger GmbH U. Co. KG. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K950045 · Karl Leibinger GmbH U. Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
77d
Days
Class 2
Risk

K950045 is an FDA 510(k) clearance for the KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Karl Leibinger GmbH U. Co. KG (Washington, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 77 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 Karl Leibinger GmbH U. Co. KG devices

FDA 510(k) Submission Details - K950045

510(k) Number K950045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1995
Decision Date March 23, 1995
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 257
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K950045.
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