Cleared Traditional

EVOCLEAN CLEANsert Ultrasonic Insert (K210832) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210832 · Ttbio Corp. · Dental device
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Feb 2022
Decision
320d
Days
Class 2
Risk

K210832 is an FDA 510(k) clearance for the EVOCLEAN CLEANsert Ultrasonic Insert. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Ttbio Corp. (Taichung, TW). The FDA issued a Cleared decision on February 2, 2022 after a review of 320 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ttbio Corp. devices

Submission Details

510(k) Number K210832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2021
Decision Date February 02, 2022
Days to Decision 320 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
193d slower than avg
Panel avg: 127d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K210832.
Combi Touch
K231391 · Mectron S.P.A. · May 2023
Endo Ultrasonic Activator
K222096 · Foshan Coxo Medical Instrument Co., Ltd. · Mar 2023
Ultrasonic Endo Activation Device (Model:Actor I pro)
K213947 · Changzhou Bomedent Medical Technology Co.,Ltd · Sep 2022
Dental Scaler and Air Polisher
K203615 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2021
EndoPilot2
K202906 · Schlumbohm GmbH & Co. KG · Apr 2021
GentleWave X
K203302 · Sonendo, Inc. · Feb 2021