Cleared Traditional

K083432 - DRILL FREE MMF SCREW

K083432 is the FDA 510(k) clearance for DRILL FREE MMF SCREW by KLS-Martin L.P.. It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K083432 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
131d
Days
Class 2
Risk

K083432 is an FDA 510(k) clearance for the DRILL FREE MMF SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 131 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K083432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date March 31, 2009
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
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 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K083432.
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RAPIDSORB PLUS SCREW SYSTEM
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SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · Synthes (Usa) · Apr 2005
STRYKER MMF SCREW
K050535 · Stryker Instruments · Mar 2005
KLS MARTIN DRILL-FREE MMF SCREW
K042573 · KLS-Martin L.P. · Oct 2004