Acteon Tip SO4 Morita

Acteon Tip SO4 Morita (F58454) is a Class II device made by Satelec, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 03609820584546), 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	Number03609820584546 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 03609820584546

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Withdrawn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 SO4 MORITA, F58454
Description: Fine condenser, length 40mm, taper 4% The SO4 tip is designed for lateral condensation of gutta percha by heating effect. It is used dry, without irrigation

Primary DI / UDI-DI: 03609820584546
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

Other devices from Satelec

Acteon PZ1 II

Class II
Acteon PZ3 II

Class II
Buse Perio Maint Air N Go Easy F10128

Class I
Sp Newtron LED 4K3.7V Us Emb F55542

Class II

See all devices from Satelec →

Properties

Sterilise before use
Prescription use
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (10, all answered No)