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Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Hard/soft-tissue ultrasonic surgical system FDA UDI
Device Name
To be inserted deeply and with great care, along the periodontal ligament, between the root and the alveolar bone. Length of active part: 9mm Alternative DI : 10887587009742 FDA UDI
Model / Reference
03.000.407S FDA UDI
Description
To be inserted deeply and with great care, along the periodontal ligament, between the root and the alveolar bone. Length of active part: 9mm Alternative DI : 10887587009742 FDA UDI

Identifiers

Catalog Number
F87707 FDA UDI
Primary DI / UDI-DI
03609820877075 FDA UDI
510(k) Number
K100410 FDA UDI
FDA Product Code
JDX FDA UDI
GMDN Term
Hard/soft-tissue ultrasonic surgical system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.4580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hard/soft-tissue ultrasonic surgical system

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

Similar devices

Also classified as Hard/soft-tissue ultrasonic surgical system.

Cleared under the same submission

K100410 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Satelec

Sources (1)

  • FDA UDI 9f7aa245-2cbe-4e6e-af24-a6f0e113475f 36 fields · synced May 30, 2026