← Back to catalogue

Acteon

FDA UDI

Class I (US FDA UDI)

by Satelec

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Dental abrasive air jet system handpiece FDA UDI
Device Name
Adaptable handpiece for either SUPRA and SUB-gingival treatments 4 AIR-N-GO® nozzles for perfect removal of pathogenic bacteria Complete range of powders to provide customized solutions for all clinical needs Gentle and efficient treatments for better patient comfort FDA UDI
Model / Reference
AIR N GO EASY SIRONA x 2BUSES FDA UDI
Description
Adaptable handpiece for either SUPRA and SUB-gingival treatments 4 AIR-N-GO® nozzles for perfect removal of pathogenic bacteria Complete range of powders to provide customized solutions for all clinical needs Gentle and efficient treatments for better patient comfort FDA UDI

Identifiers

Catalog Number
F10131 FDA UDI
Primary DI / UDI-DI
03609820101316 FDA UDI
510(k) Number
K110379 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental abrasive air jet system handpiece FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental abrasive air jet system handpiece

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

Similar devices

Also classified as Dental abrasive air jet system handpiece.

Cleared under the same submission

K110379 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Satelec

Sources (1)

  • FDA UDI 952bfdb1-2814-4f0b-84fa-7117127e3795 36 fields · synced Jun 8, 2026