Cleared Traditional

K130137 - BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER

K130137 is an FDA 510(k) clearance for BIOSONIC SUVI PIEZEOELECTRIC SCALER AND..., manufactured by Coltene/Whaledent. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K130137 · Coltene/Whaledent · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
217d
Days
Class 2
Risk

K130137 is an FDA 510(k) clearance for the BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Coltene/Whaledent (Cleveland, US). The FDA issued a Cleared decision on August 23, 2013 after a review of 217 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 Coltene/Whaledent devices

FDA 510(k) Submission Details - K130137

510(k) Number K130137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2013
Decision Date August 23, 2013
Days to Decision 217 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
90d slower than avg
Panel avg: 127d · This submission: 217d
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 83
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K130137.
PIEZON 250
K132445 · E.M.S Electro Medical Systems S.A · Dec 2013
PIEZON 150
K132443 · E.M.S Electro Medical Systems S.A · Nov 2013
R7
K130834 · Cefla S.C. · Oct 2013
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
K130693 · Aseptico, Inc. · Aug 2013
ULTRASONIC SCALER
K113717 · Nakanishi, Inc. · Mar 2013
ULTRASONIC SCALER
K113530 · Nakanishi, Inc. · Jan 2013