Cleared Traditional

PIEZOTOME 2 (K091331) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 12
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
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326 · Sherwood Medical Co. · Oct 1979