Cleared Traditional

K210832 - EVOCLEAN CLEANsert Ultrasonic Insert

K210832 is an FDA 510(k) clearance for EVOCLEAN CLEANsert Ultrasonic Insert, manufactured by Ttbio Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 320-day FDA review.

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

FDA 510(k) Submission Details - K210832

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.

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 K210832.
Combi Touch
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K203615 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2021
EndoPilot2
K202906 · Schlumbohm GmbH & Co. KG · Apr 2021
GentleWave X
K203302 · Sonendo, Inc. · Feb 2021