Cleared Traditional

K091331 - PIEZOTOME 2

K091331 is an FDA 510(k) clearance for PIEZOTOME 2, manufactured by Satelec. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K091331 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
220d
Days
Class 2
Risk

K091331 is an FDA 510(k) clearance for the PIEZOTOME 2. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on December 11, 2009 after a review of 220 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 Satelec devices

FDA 510(k) Submission Details - K091331

510(k) Number K091331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2009
Decision Date December 11, 2009
Days to Decision 220 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
93d slower than avg
Panel avg: 127d · This submission: 220d
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 29
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K091331.
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
IMPLANT CENTER 2
K091252 · Satelec · Jul 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
STRAUMANN GUIDED INSTRUMENTS
K082532 · Straumann USA · Oct 2008