Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name: ACTEON FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Suprasson handpiece autoclavable Acteon FDA UDI
Model / Reference: DUAL HANDPIECE ULTRASONIC KIT FDA UDI
Description: Suprasson handpiece autoclavable Acteon FDA UDI

Identifiers

Catalog Number: F55409 FDA UDI
Primary DI / UDI-DI: 03609820554099 FDA UDI
510(k) Number: K033764 FDA UDI
FDA Product Code: ELC FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system

Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ultrasonic dental scaling/debridement system.

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Cleared under the same submission

K033764 also covers:

ACTEON — Satelec
ACTEON — Satelec

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Satelec

Sources (1)

FDA UDI 8af26866-fd1d-4c53-b465-a0986bce0dd4 36 fields · synced May 29, 2026