Cleared Traditional

K102218 - COMPACT PIEZO P2K

K102218 is an FDA 510(k) clearance for COMPACT PIEZO P2K, manufactured by Mectron S.P.A.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K102218 · Mectron S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
171d
Days
Class 2
Risk

K102218 is an FDA 510(k) clearance for the COMPACT PIEZO P2K, POWERCARE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on January 24, 2011 after a review of 171 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Mectron S.P.A. devices

FDA 510(k) Submission Details - K102218

510(k) Number K102218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2010
Decision Date January 24, 2011
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 75
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K102218.
ULTRASONIC SCALER
K113717 · Nakanishi, Inc. · Mar 2013
ULTRASONIC SCALER
K113530 · Nakanishi, Inc. · Jan 2013
EMS AIR-FLOW MASTER PIEZON
K110173 · E.M.S Electro Medical Systems S.A · Apr 2011
EMS MINIMASTER LED
K093723 · E.M.S Electro Medical Systems S.A · Sep 2010
EMS PIEZON MASTER 700
K093000 · E.M.S Electro Medical Systems S.A · Jul 2010
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010