Cleared Traditional

EMS PIEZON MASTER SURGERY (K072146) - FDA 510(k) Clearance

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

K072146 · E.M.S Electro Medical Systems S.A · Dental device
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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 47
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