K140233 - ULTRASONIC SCALER (FDA 510(k) Clearance)

K140233 is an FDA 510(k) clearance for the ULTRASONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nanning Baolai Medical Instrument Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on April 6, 2015 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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