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)
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.

View all Satelec - Acteon, Inc. devices

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
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · 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 33
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K112188.
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
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K082649 · Synthes (Usa) · Apr 2009