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

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.

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