Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name: ACTEON FDA UDI
Generic Name: Dental ultrasonic surgical system handpiece FDA UDI
Device Name: Piezotome® 2 pack (without tip) Delivered with an autoclavable Piezotome® 2 handpiece with cord and a Piezotome® dynamometric wrench FDA UDI
Model / Reference: PACK PIEZOTOME 2 FDA UDI
Description: Piezotome® 2 pack (without tip) Delivered with an autoclavable Piezotome® 2 handpiece with cord and a Piezotome® dynamometric wrench FDA UDI

Identifiers

Catalog Number: F87523 FDA UDI
Primary DI / UDI-DI: 03609820875231 FDA UDI
510(k) Number: K091331 FDA UDI
FDA Product Code: DZI FDA UDI
GMDN Term: Dental ultrasonic surgical system handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 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: Dental ultrasonic surgical system handpiece

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

Similar devices

Also classified as Dental ultrasonic surgical system handpiece.

MECTRON — MECTRON SPA · Class II
PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
MECTRON — MECTRON SPA · Class I
MECTRON — MECTRON SPA · Class II
Johnson-Promident — Young Innovations, Inc. · Class I
Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II

Cleared under the same submission

K091331 also covers:

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 d0b7b024-be42-4584-b873-8ad2ecb51423 36 fields · synced May 30, 2026