Cleared Traditional

K963740 - LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS

K963740 is an FDA 510(k) clearance for LEIBINGER - LUHR SMALL MANDIBULAR BONE ..., manufactured by Howmedica Leibinger, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K963740 · Howmedica Leibinger, Inc. · Dental device
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Oct 1996
Decision
41d
Days
Class 2
Risk

K963740 is an FDA 510(k) clearance for the LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Howmedica Leibinger, Inc. (Dallas, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 41 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 Howmedica Leibinger, Inc. devices

FDA 510(k) Submission Details - K963740

510(k) Number K963740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date October 28, 1996
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 238
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K963740.
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THE BIOPLATE FIXATION SYSTEM
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K961421 · Synthes (Usa) · Jun 1996
TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)
K960514 · Anspach Fixation Systems · Apr 1996