Tupel 3D

FDA UDI

Class II (US FDA UDI)

by Tupel Ltd

Identity

Trade Name: Tupel 3D FDA UDI
Generic Name: Dental milling system, CAD/CAM, chairside FDA UDI
Device Name: A 3D desktop dental scanner FDA UDI
Model / Reference: Desktop 3D Dental Scanner FDA UDI
Description: A 3D desktop dental scanner FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007842900 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Dental milling system, CAD/CAM, chairside 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental milling system, CAD/CAM, chairside

Tupel 3D by Tupel Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CS 3500 3D Scanner Collar — CARESTREAM HEALTH, INC. · Class II
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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: Tupel Ltd

Sources (1)

FDA UDI 8a663d2f-00ae-4d1a-b256-4bbfabedd20d 34 fields · synced Jun 1, 2026