Cleared Traditional

Ultrasonic Endo Activation Device (Model:Actor I pro) (K213947) - FDA 510(k) Clearance

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

K213947 · Changzhou Bomedent Medical Technology Co.,Ltd · Dental device
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Sep 2022
Decision
265d
Days
Class 2
Risk

K213947 is an FDA 510(k) clearance for the Ultrasonic Endo Activation Device (Model:Actor I pro). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on September 8, 2022 after a review of 265 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 Changzhou Bomedent Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K213947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2021
Decision Date September 08, 2022
Days to Decision 265 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
138d slower than avg
Panel avg: 127d · This submission: 265d
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 K213947.
Proxeo ULTRA (PB-510, PB-520 and PB-530)
K223173 · W&H Dentalwerk Buermoss GmbH · Jul 2023
Combi Touch
K231391 · Mectron S.P.A. · May 2023
Endo Ultrasonic Activator
K222096 · Foshan Coxo Medical Instrument Co., Ltd. · Mar 2023
EVOCLEAN CLEANsert Ultrasonic Insert
K210832 · Ttbio Corp. · Feb 2022
Dental Scaler and Air Polisher
K203615 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2021
EndoPilot2
K202906 · Schlumbohm GmbH & Co. KG · Apr 2021