BioSonic 60014245

by Coltene/Whaledent Inc.

BioSonic 60014245 is a Class II device made by Coltene/Whaledent Inc., cleared under FDA 510(k) K130137 on 23 Aug 2013 and listed in FDA GUDID since 3 Jun 2016 (UDI-DI D661600142450), 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	NumberD661600142450 UDI-DI	Date3 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK130137	Date23 Aug 2013Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K130137

Across registries

2 registries list this device

FDA 510(k) K130137 decided 23 Aug 2013 Active
FDA GUDID UDI-DI D661600142450 listed 3 Jun 2016 Listed

Timeline

2 dated events

23 Aug 2013 Cleared FDA 510(k) K130137
3 Jun 2016 Listed FDA GUDID D661600142450

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Withdrawn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: 60014245

Primary DI / UDI-DI: D661600142450
510(k) Number: K130137
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

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Properties

Serial number

Other properties (14, all answered No)