Cleared Traditional

K093464 - RAPIDSORB PLUS SCREW SYSTEM

K093464 is an FDA 510(k) clearance for RAPIDSORB PLUS SCREW SYSTEM, 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 80-day FDA review.

K093464 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
80d
Days
Class 2
Risk

K093464 is an FDA 510(k) clearance for the RAPIDSORB PLUS SCREW SYSTEM. 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 January 25, 2010 after a review of 80 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 - K093464

510(k) Number K093464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date January 25, 2010
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
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 K093464.
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011
SALVIN DENTAL SPECIALTIES FIXATION SCREW
K100182 · Salvin Dental Specialties, Inc. · May 2010
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
K093719 · Osteogenics Biomedical, Inc. · Mar 2010
MILTEX MEMBRANE TACK KIT
K092855 · Miltex, Inc. · Dec 2009
DRILL FREE MMF SCREW
K083432 · KLS-Martin L.P. · Mar 2009
STOMA BONE BLOCK SCREW
K080430 · Storz AM Mark GmbH · Nov 2008
K093464 · RAPIDSORB PLUS SCREW SYSTEM
Download PDF FDA Summary Synthes (Usa)