Cleared Traditional

K990140 - NORMED BONE TRANSPORT

K990140 is an FDA 510(k) clearance for NORMED BONE TRANSPORT, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K990140 · Ace Surgical Supply Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
65d
Days
Class 2
Risk

K990140 is an FDA 510(k) clearance for the NORMED BONE TRANSPORT. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on March 25, 1999 after a review of 65 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 Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K990140

510(k) Number K990140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date March 25, 1999
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
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 276
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K990140.
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · Biomedics · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
DRG TITANIUM BONE PLATE
K990920 · Doctor'S Research Group, Inc. · Jun 1999
MACROPORE PROTECTIVE SHEET
K983360 · Pacific Materials and Interfaces · Mar 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · Bionx Implants, Inc. · Feb 1999
OSTEO-MESH TM-300
K984230 · Osteogenics Biomedical, Inc. · Feb 1999