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Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece FDA UDI
Device Name
This medical device is intended for prophylaxis—scaling, periodontics, endodontics, and for preservation and restoration dentistry, including prosthesis. The electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece. This is connected to the medical device via a cord. The handpiece is comprised of a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. Mechanical vibrations are then transmitted to the tip or dental file attached to the end of the ultrasonic handpiece. FDA UDI
Model / Reference
ULTRAWAVE HAND PIECE FDA UDI
Description
This medical device is intended for prophylaxis—scaling, periodontics, endodontics, and for preservation and restoration dentistry, including prosthesis. The electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece. This is connected to the medical device via a cord. The handpiece is comprised of a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. Mechanical vibrations are then transmitted to the tip or dental file attached to the end of the ultrasonic handpiece. FDA UDI

Identifiers

Catalog Number
F12101 FDA UDI
Primary DI / UDI-DI
03609820121017 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece

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

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Satelec

Sources (1)

  • FDA UDI 44ad78eb-421b-4af8-a5dc-848985d44fd4 35 fields · synced Jun 8, 2026