Biosonic Ultrasonic Scaler System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983727

Identifiers

510(k) Number: K983727 FDA 510(k)
FDA Product Code: ELC FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.4850 FDA 510(k)
Regulation Number: 872.4850 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

A comprehensive ultrasonic scaler system designed for use in dental practices, providing a safe and effective way to remove plaque, tartar, and other debris from teeth. The system features advanced sound wave technology, adjustable intensity settings, and easy-to-use controls.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K983727	Class II	Active

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Manufacturer

Manufacturer: Coltene/Whaledent Inc.
FDA Applicant: Coltene/Whaledent, Inc.

Sources (1)

FDA 510(k) K983727 24 fields · synced Jul 12, 2026