Cleared Traditional

K984230 - OSTEO-MESH TM-300

K984230 is an FDA 510(k) clearance for OSTEO-MESH TM-300, manufactured by Osteogenics Biomedical, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K984230 · Osteogenics Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
71d
Days
Class 2
Risk

K984230 is an FDA 510(k) clearance for the OSTEO-MESH TM-300. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteogenics Biomedical, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 71 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 Osteogenics Biomedical, Inc. devices

FDA 510(k) Submission Details - K984230

510(k) Number K984230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date February 04, 1999
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
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 272
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K984230.
NORMED BONE TRANSPORT
K990140 · Ace Surgical Supply Co., Inc. · Mar 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
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885 · Howmedica, Inc. · Jan 1999
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010
K983535 · Hans Hermann GmbH · Dec 1998
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998