Cleared Traditional

K082649 - SYNTHES 90 DEGREE SCREWDRIVER

K082649 is an FDA 510(k) clearance for SYNTHES 90 DEGREE SCREWDRIVER, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K082649 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
230d
Days
Class 2
Risk

K082649 is an FDA 510(k) clearance for the SYNTHES 90 DEGREE SCREWDRIVER. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 30, 2009 after a review of 230 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K082649

510(k) Number K082649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date April 30, 2009
Days to Decision 230 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
103d slower than avg
Panel avg: 127d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZI Drill, Bone, Powered

All 44
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K082649.
PIEZO BONE SURGERY
K111290 · Guilin Woodpecker Medical Instrument Co., Ltd. · Nov 2011
PIEZOTOME 2
K091331 · Satelec · Dec 2009
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009
STRAUMANN GUIDED INSTRUMENTS
K082532 · Straumann USA · Oct 2008
VARIOSURG
K073678 · Nakanishi, Inc. · Jul 2008
EMS PIEZON MASTER SURGERY
K072146 · E.M.S Electro Medical Systems S.A · Dec 2007