Cleared Traditional

K213947 - Ultrasonic Endo Activation Device (Mode...

K213947 is an FDA 510(k) clearance for Ultrasonic Endo Activation Device (Mode..., manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

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

FDA 510(k) Submission Details - K213947

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.

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 K213947.
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