Cleared Traditional

K041887 - SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL ...

K041887 is the FDA 510(k) clearance for SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL ... by Synthes (Usa). It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K041887 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
38d
Days
Class 2
Risk

K041887 is an FDA 510(k) clearance for the SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 19, 2004 after a review of 38 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 Synthes (Usa) devices

Submission Details

510(k) Number K041887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date August 19, 2004
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 K041887.
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
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
K031807 · Synthes (Usa) · Jul 2003
THE AUTOTAC SYSTEM TITANIUM TACK
K022790 · BioHorizons Implant Systems, Inc. · Aug 2002
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850 · Synthes (Usa) · Jun 2002