Cleared Traditional

K093719 - PRO-FIX PRECISION FIXATION SYSTEM MODEL...

K093719 is an FDA 510(k) clearance for PRO-FIX PRECISION FIXATION SYSTEM MODEL..., manufactured by Osteogenics Biomedical, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K093719 · Osteogenics Biomedical, Inc. · Dental device
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Mar 2010
Decision
89d
Days
Class 2
Risk

K093719 is an FDA 510(k) clearance for the PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on March 1, 2010 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteogenics Biomedical, Inc. devices

FDA 510(k) Submission Details - K093719

510(k) Number K093719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date March 01, 2010
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 56
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