Cleared Traditional

K151248 - PIEZOSURGERY WHITE

K151248 is an FDA 510(k) clearance for PIEZOSURGERY WHITE, manufactured by Mectron S.P.A.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K151248 · Mectron S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
116d
Days
Class 2
Risk

K151248 is an FDA 510(k) clearance for the PIEZOSURGERY WHITE. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on September 4, 2015 after a review of 116 days - within the typical 510(k) review window.

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 Mectron S.P.A. devices

FDA 510(k) Submission Details - K151248

510(k) Number K151248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date September 04, 2015
Days to Decision 116 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
12d faster than avg
Panel avg: 128d · This submission: 116d
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 Consultant

Donawa Lifescience Consulting Srl
Mr. Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZI Drill, Bone, Powered

All 49
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K151248.
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K133488 · W&H Dentalwerk Buermoos GmbH · Oct 2014