Cleared Traditional

K091227 - PIEZOSURGERY 3 (FDA 510(k) Clearance)

Also includes:
OSSTEM PIEZO

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

K091227 · Piezosurgery S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
245d
Days
Class 2
Risk

K091227 is an FDA 510(k) clearance for the PIEZOSURGERY 3. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Piezosurgery S.R.L. (Brescia, IT). The FDA issued a Cleared decision on December 29, 2009 after a review of 245 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 Piezosurgery S.R.L. devices

Submission Details

510(k) Number K091227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2009
Decision Date December 29, 2009
Days to Decision 245 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
118d slower than avg
Panel avg: 127d · This submission: 245d
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.