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Scanner ORTHO Scan S300 Arti

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name
Scanner ORTHO Scan S300 Arti FDA UDI
Generic Name
Dental milling system, CAD/CAM, laboratory FDA UDI
Device Name
Scanner ORTHO Scan S300 Arti (part of product set) FDA UDI
Model / Reference
BG001644 FDA UDI
Description
Scanner ORTHO Scan S300 Arti (part of product set) FDA UDI

Identifiers

Primary DI / UDI-DI
D800BG001644 FDA UDI
FDA Product Code
NOF FDA UDI
GMDN Term
Dental milling system, CAD/CAM, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3661 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental milling system, CAD/CAM, laboratory

Scanner ORTHO Scan S300 Arti by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental milling system, CAD/CAM, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zirkonzahn GmbH

Sources (1)

  • FDA UDI dd3acbbc-12ab-476b-a40d-2b608bda54a1 33 fields · synced Jun 8, 2026