Acteon Tip H1

Acteon Tip H1 (F00366) is a Class II device made by Satelec, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 03609820003665), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

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	Number03609820003665 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 03609820003665

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Acteon
Generic name: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Ref / Catalog: TIP H1, F00366

Primary DI / UDI-DI: 03609820003665
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

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
Prescription use
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (10, all answered No)