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Acteon PZ3 II

by Satelec

Acteon PZ3 II (F87574) is a Class II device made by Satelec, cleared under FDA 510(k) K091252 on 22 Jul 2009 and listed in FDA GUDID since 13 Oct 2026 (UDI-DI 03609820875743), active as of 23 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 23 Oct 2026

Documents

510(k) K091252

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03609820875743 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091252 Date22 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091252 decided 22 Jul 2009 Active
  • FDA GUDID UDI-DI 03609820875743 listed 13 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091252
  2. Listed FDA GUDID 03609820875743

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  • Withdrawn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 ultrasonic surgical system handpiece tip
Model / Ref / Catalog
PZ3 II, F87574
Primary DI / UDI-DI
03609820875743
510(k) Number
FDA product code
DZI
GMDN term
Dental ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K091252)

and 8 more cleared under K091252

Other devices from Satelec

See all devices from Satelec →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)