Ultrasonic Endo Activation Device (Model:Actor I pro)— 510(k) K213947

Name: FDA 510(k) clearance K213947
Creator: U.S. Food and Drug Administration
Published: 2022-09-08

Substantially Equivalent

Changzhou Bomedent Medical Technology Co.,Ltd

FDA 510(k) clearance K213947 for Ultrasonic Endo Activation Device (Model:Actor I pro), Substantially Equivalent on 2022-09-08. Applicant: Changzhou Bomedent Medical Technology Co.,Ltd. Device class: 2.

Clearance details

Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2021-12-17
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELC

view all

K260773 — Varios Combi Pro22026-03-10
K253254 — GBT Machine Airflow Prophylaxis Master2026-01-28
K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more2025-09-19
K242317 — Integrated Endo System (Meet Endo-II)2025-02-13
K233844 — OdneClean2024-08-08

More clearances from Changzhou Bomedent Medical Technology Co.,Ltd

view all

K203836 — BOMEDENT Apex locator, WISMY Apex locator2021-03-30
K191276 — Dental Electrical Motor iRoot Pro2020-06-30

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.