Cleared Traditional

K950595 - LUHR MANDIBULAR/SMALL FIXATION IMPLANTS

K950595 is an FDA 510(k) clearance for LUHR MANDIBULAR/SMALL FIXATION IMPLANTS, manufactured by Howmedica Corp.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K950595 · Howmedica Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
153d
Days
Class 2
Risk

K950595 is an FDA 510(k) clearance for the LUHR MANDIBULAR/SMALL FIXATION IMPLANTS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 153 days - an extended review 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: 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K950595

510(k) Number K950595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date July 12, 1995
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K950595.
MICRO TITANIUM PLATE SYSTEM
K951688 · Medicon EG · Jul 1995
TITANIUM MINIPLATE SYSTEM
K951690 · Medicon EG · Jul 1995
CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM
K951691 · Medicon EG · Jul 1995
MINIBONEPLATE SYSTEM
K951392 · Ace Surgical Supply Co., Inc. · May 1995
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · KLS-Martin L.P. · Oct 1994
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994