Cleared Traditional

K060275 - PIEZOTOME

K060275 is an FDA 510(k) clearance for PIEZOTOME, manufactured by Satelec. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060275 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
90d
Days
Class 2
Risk

K060275 is an FDA 510(k) clearance for the PIEZOTOME. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on May 3, 2006 after a review of 90 days - within the typical 510(k) review window.

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 Satelec devices

FDA 510(k) Submission Details - K060275

510(k) Number K060275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2006
Decision Date May 03, 2006
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 74
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K060275.
PERIOSCAN, MODEL: D 3496
K072107 · Sirona Dental Systems GmbH · Feb 2008
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · Dentsply International, Inc. · May 2007
ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007
J. MORITA AZ ULTRASONIC SYSTEM
K053030 · J. Morita USA, Inc. · Nov 2005
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · Dentsply Intl. · Sep 2005
SURPASSON P5 NEWTRON
K050895 · Satelec · Apr 2005