Cleared Traditional

K012486 - OSTEOMED BIORESORBABLE FIXATION SYSTEM

K012486 is an FDA 510(k) clearance for OSTEOMED BIORESORBABLE FIXATION SYSTEM, manufactured by Osteomed Corp.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K012486 · Osteomed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
167d
Days
Class 2
Risk

K012486 is an FDA 510(k) clearance for the OSTEOMED BIORESORBABLE FIXATION SYSTEM. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on January 16, 2002 after a review of 167 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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

FDA 510(k) Submission Details - K012486

510(k) Number K012486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date January 16, 2002
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 78
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K012486.
THE AUTOTAC SYSTEM TITANIUM TACK
K022790 · BioHorizons Implant Systems, Inc. · Aug 2002
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850 · Synthes (Usa) · Jun 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522 · Walter Lorenz Surgical, Inc. · May 2002
BIOPLATE RESORBABLE BONE SCREW
K012908 · Bioplate, Inc. · Nov 2001
THE AUTOTAC SYSTEM
K011675 · BioHorizons Implant Systems, Inc. · Jun 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690 · Synthes (Usa) · May 2001