Cleared Traditional

K994154 - MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES

K994154 is an FDA 510(k) clearance for MOD LINE OF MOLINA DISTRACTORS, manufactured by KLS-Martin L.P.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K994154 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
68d
Days
Class 2
Risk

K994154 is an FDA 510(k) clearance for the MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 68 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 KLS-Martin L.P. devices

FDA 510(k) Submission Details - K994154

510(k) Number K994154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date February 15, 2000
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 K994154.
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K001530 · Bioplate, Inc. · Jul 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · Bionx Implants, Inc. · Jun 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MODUS SAGITTAL SPLIT PLATE
K993862 · The Straumann Co. · Dec 1999
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · Medartis AG · Nov 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · Medartis AG · Nov 1999