BioSonic USC4S

by Coltene/Whaledent Inc.

BioSonic USC4S is a Class II device made by Coltene/Whaledent Inc., cleared under FDA 510(k) K053555 on 21 Aug 2006 and listed in FDA GUDID since 17 Jun 2016 (UDI-DI D661USC4S0), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD661USC4S0 UDI-DI	Date17 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK053555	Date21 Aug 2006Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K053555

Across registries

2 registries list this device

FDA 510(k) K053555 decided 21 Aug 2006 Active
FDA GUDID UDI-DI D661USC4S0 listed 17 Jun 2016 Listed

Timeline

2 dated events

21 Aug 2006 Cleared FDA 510(k) K053555
17 Jun 2016 Listed FDA GUDID D661USC4S0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: BioSonic
Generic name: Ultrasonic dental scaling/debridement system
Model / reference: USC4S

Primary DI / UDI-DI: D661USC4S0
510(k) Number: K053555
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system

Device class: Class II
Regulation number: 872.4850
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Lot / batch number

Other properties (13, all answered No)