Cleared Traditional

K003883 - MOLINA ORBITAL MALAR DISTRACTOR

K003883 is an FDA 510(k) clearance for MOLINA ORBITAL MALAR DISTRACTOR, 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 39-day FDA review.

K003883 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
39d
Days
Class 2
Risk

K003883 is an FDA 510(k) clearance for the MOLINA ORBITAL MALAR DISTRACTOR. 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 January 23, 2001 after a review of 39 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 - K003883

510(k) Number K003883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date January 23, 2001
Days to Decision 39 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
88d faster than avg
Panel avg: 127d · This submission: 39d
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 K003883.
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · Walter Lorenz Surgical, Inc. · Feb 2001
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
K002426 · Bioplate, Inc. · Jan 2001
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE
K994060 · Bioplate, Inc. · Jan 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
K003756 · Bionx Implants, Inc. · Jan 2001