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ACTEON AIR N GO EASY SIRONA x 2BUSES

by Satelec

ACTEON AIR N GO EASY SIRONA x 2BUSES (F10131) is a Class I device made by Satelec, cleared under FDA 510(k) K110379 on 8 Dec 2011 and listed in FDA GUDID since 23 Dec 2019 (UDI-DI 03609820101316), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K110379

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03609820101316 UDI-DI Date23 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110379 Date8 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110379 decided 8 Dec 2011 Active
  • FDA GUDID UDI-DI 03609820101316 listed 23 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110379
  2. Listed FDA GUDID 03609820101316

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acteon
Generic name
Dental abrasive air jet system handpiece
Model / Ref / Catalog
AIR N GO EASY SIRONA x 2BUSES, F10131
Primary DI / UDI-DI
03609820101316
510(k) Number
FDA product code
EFB
GMDN term
Dental abrasive air jet system handpiece
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental abrasive air jet system handpiece

Cleared under the same submission (K110379)

and 1 more cleared under K110379

Other devices from Satelec

See all devices from Satelec →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)