K053555 - ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L (FDA 510(k) Clearance)

K053555 is an FDA 510(k) clearance for the ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 244 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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