Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name: ACTEON FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: Scanwave PEN OEM is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390nm-505nm. FDA UDI
Model / Reference: HANDPIECE SCANWAVE OEM PEN FDA UDI
Description: Scanwave PEN OEM is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390nm-505nm. FDA UDI

Identifiers

Catalog Number: F05510 FDA UDI
Primary DI / UDI-DI: 03609820055107 FDA UDI
510(k) Number: K131906 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

Category: Dental/surgical polymerization lamp

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

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Cleared under the same submission

K131906 also covers:

ACTEON — Satelec

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 88f23128-795c-4068-a665-5ea1d7b564ee 36 fields · synced May 30, 2026