Cleared Traditional

K082649 - SYNTHES 90 DEGREE SCREWDRIVER

K082649 is the FDA 510(k) clearance for SYNTHES 90 DEGREE SCREWDRIVER by Synthes (Usa). It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 23
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K082649.
PIEZOTOME CUBE
K172137 · Satelec - Acteon Group · May 2018
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
STRAUMANN GUIDED INSTRUMENTS
K082532 · Straumann USA · Oct 2008
VARIOSURG
K073678 · Nakanishi, Inc. · Jul 2008
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270 · Linvatec Corp. · Apr 2006