Cleared Traditional

K050606 - SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)

K050606 is an FDA 510(k) clearance for SYNTHES 1.0MM TI. CORTEX, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K050606 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
27d
Days
Class 2
Risk

K050606 is an FDA 510(k) clearance for the SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL). Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 6, 2005 after a review of 27 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.

FDA 510(k) Submission Details - K050606

510(k) Number K050606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2005
Decision Date April 06, 2005
Days to Decision 27 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
101d faster than avg
Panel avg: 128d · This submission: 27d
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 80
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K050606.
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
K073342 · Salvin Dental Specialties, Inc. · Mar 2008
ALPHA BIO BONE FIXATION SCREW SYSTEM
K063769 · Alpha-Bio Tec , Ltd. · Mar 2007
STOMA BONE SCREW
K051871 · Storz AM Mark GmbH · Oct 2005
BONE BLOCK FIXATION SET
K050515 · Straumann USA, Inc. · Apr 2005
STRYKER MMF SCREW
K050535 · Stryker Instruments · Mar 2005
KLS MARTIN DRILL-FREE MMF SCREW
K042573 · KLS-Martin L.P. · Oct 2004
K050606 · SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
Download PDF FDA Summary Synthes (Usa)