Cleared Traditional

K072146 - EMS PIEZON MASTER SURGERY

K072146 is the FDA 510(k) clearance for EMS PIEZON MASTER SURGERY by E.M.S Electro Medical Systems S.A. It is a Class 2 Dental device (product code DZI) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K072146 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
137d
Days
Class 2
Risk

K072146 is an FDA 510(k) clearance for the EMS PIEZON MASTER SURGERY. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on December 18, 2007 after a review of 137 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 E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K072146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2007
Decision Date December 18, 2007
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
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 24
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K072146.
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
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
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · Stryker Instruments · Aug 2003