Cleared Traditional

K140233 - ULTRASONIC SCALER

K140233 is an FDA 510(k) clearance for ULTRASONIC SCALER, manufactured by Nanning Baolai Medical Instrument Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K140233 · Nanning Baolai Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
431d
Days
Class 2
Risk

K140233 is an FDA 510(k) clearance for the ULTRASONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nanning Baolai Medical Instrument Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on April 6, 2015 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nanning Baolai Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K140233

510(k) Number K140233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date April 06, 2015
Days to Decision 431 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
304d slower than avg
Panel avg: 127d · This submission: 431d
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 82
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K140233.
Sonendo GentleWave System
K190359 · Sonendo, Inc. · Mar 2019
AW-100
K171150 · Micron Corporation · Mar 2018
Cavitron Touch Ultrasonic Scaling System
K150535 · Dentsply International, Inc. · Jun 2015
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
K140990 · E.M.S Electro Medical Systems S.A · Feb 2015
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