Acteon Piezotome Cube Emb Canada

Acteon Piezotome Cube Emb Canada (F50117) is a Class II device made by Satelec, cleared under FDA 510(k) K172137 on 3 May 2018 and listed in FDA GUDID since 24 Dec 2019 (UDI-DI 03609820501178), 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	Number03609820501178 UDI-DI	Date24 Dec 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK172137	Date3 May 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03609820501178
FDA 510(k) database 510(k) number K172137

Across registries

2 registries list this device

FDA 510(k) K172137 decided 3 May 2018 Active
FDA GUDID UDI-DI 03609820501178 listed 24 Dec 2019 Listed

Timeline

2 dated events

3 May 2018 Cleared FDA 510(k) K172137
24 Dec 2019 Listed FDA GUDID 03609820501178

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Acteon
Generic name: Dental ultrasonic surgical system
Model / Ref / Catalog: PIEZOTOME CUBE EMB CANADA, F50117

Primary DI / UDI-DI: 03609820501178
510(k) Number: K172137
FDA product code: DZI
GMDN term: Dental ultrasonic surgical system

Device class: Class II
Regulation number: 872.4120
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)