Cleared Traditional

K012486 - OSTEOMED BIORESORBABLE FIXATION SYSTEM (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

Device Classification

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 79
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K012486.
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