Cleared Traditional

K112188 - PIEZOTOME SOLO

K112188 is an FDA 510(k) clearance for PIEZOTOME SOLO, manufactured by Satelec - Acteon, Inc.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K112188 · Satelec - Acteon, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
189d
Days
Class 2
Risk

K112188 is an FDA 510(k) clearance for the PIEZOTOME SOLO. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Satelec - Acteon, Inc. (Mt. Laurel, US). The FDA issued a Cleared decision on February 3, 2012 after a review of 189 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 - K112188

510(k) Number K112188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date February 03, 2012
Days to Decision 189 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
61d slower than avg
Panel avg: 128d · This submission: 189d
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 K112188.
ULTRASONIC SURGERY
K121620 · Dmetec.Co., Ltd. · Dec 2012
PIEZOSURGERY TOUCH
K122322 · Mectron S.P.A. · Dec 2012
ULTRASONIC SURGERY MACHINE
K113152 · Dmetec.Co., Ltd. · Jun 2012
ULTRASONIC SURGICAL UNIT
K110881 · Dong IL Technology , Ltd. · Dec 2011
PIEZO BONE SURGERY
K111290 · Guilin Woodpecker Medical Instrument Co., Ltd. · Nov 2011
PIEZOSURGERY 3
K091227 · Piezosurgery S.R.L. · Dec 2009
K112188 · PIEZOTOME SOLO
Download PDF FDA Summary Satelec - Acteon, Inc.