Cleared Traditional

K113152 - ULTRASONIC SURGERY MACHINE

K113152 is an FDA 510(k) clearance for ULTRASONIC SURGERY MACHINE, manufactured by Dmetec.Co., Ltd.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K113152 · Dmetec.Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
233d
Days
Class 2
Risk

K113152 is an FDA 510(k) clearance for the ULTRASONIC SURGERY MACHINE. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Dmetec.Co., Ltd. (Glendale, US). The FDA issued a Cleared decision on June 14, 2012 after a review of 233 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.

FDA 510(k) Submission Details - K113152

510(k) Number K113152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2011
Decision Date June 14, 2012
Days to Decision 233 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
105d slower than avg
Panel avg: 128d · This submission: 233d
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 Peers - DZI Drill, Bone, Powered

All 49
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K113152.
PIEZOMED
K133488 · W&H Dentalwerk Buermoos GmbH · Oct 2014
ULTRASONIC SURGERY
K121620 · Dmetec.Co., Ltd. · Dec 2012
PIEZOSURGERY TOUCH
K122322 · Mectron S.P.A. · Dec 2012
PIEZOTOME SOLO
K112188 · Satelec - Acteon, Inc. · Feb 2012
ULTRASONIC SURGICAL UNIT
K110881 · Dong IL Technology , Ltd. · Dec 2011
PIEZO BONE SURGERY
K111290 · Guilin Woodpecker Medical Instrument Co., Ltd. · Nov 2011