Cleared Traditional

K924138 - OSTEOMED M3 SYSTEM (SBF SYSTEM)

K924138 is the FDA 510(k) clearance for OSTEOMED M3 SYSTEM (SBF SYSTEM) by Osteomed Corp.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K924138 · Osteomed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
183d
Days
Class 2
Risk

K924138 is an FDA 510(k) clearance for the OSTEOMED M3 SYSTEM (SBF SYSTEM). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on February 17, 1993 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteomed Corp. devices

Submission Details

510(k) Number K924138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date February 17, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 127d · This submission: 183d
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 164
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K924138.
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · KLS-Martin L.P. · Oct 1994
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992
MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM
K921801 · Techmedica, Inc. · Jul 1992
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991