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
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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
62d faster than avg
Panel avg: 127d · 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 197
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K990140.
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · Medartis AG · Nov 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · Medartis AG · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885 · Howmedica, Inc. · Jan 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998
ACE ALVEOLAR DISTRACTOR
K981526 · Ace Surgical Supply Co., Inc. · Nov 1998