Cleared Traditional

OSTEO-MESH TM-300 (K984230) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 97
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K984230.
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · Codman & Shurtleff, Inc. · Aug 2000
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998