Cleared Traditional

OsteoMed IMF Screw (K151195) - FDA 510(k) Clearance

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

K151195 · Osteomed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
140d
Days
Class 2
Risk

K151195 is an FDA 510(k) clearance for the OsteoMed IMF Screw. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on September 21, 2015 after a review of 140 days - within the typical 510(k) review window.

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 devices

Submission Details

510(k) Number K151195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date September 21, 2015
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
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 31
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K151195.
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RAPIDSORB PLUS SCREW SYSTEM
K093464 · Synthes (Usa) · Jan 2010
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · Synthes (Usa) · Apr 2005
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · Synthes (Usa) · Aug 2004