Trios® 4

FDA UDI

Class II (US FDA UDI)

by 3shape Trios A/S

Identity

Trade Name: TRIOS® 4 FDA UDI
Generic Name: Intraoral optical scanning system FDA UDI
Device Name: Calibration kit FDA UDI
Model / Reference: TST-02 FDA UDI
Description: Calibration kit FDA UDI

Identifiers

Primary DI / UDI-DI: 05902729752909 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Intraoral optical scanning system 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoral optical scanning system

Trios® 4 by 3shape Trios A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoral optical scanning system.

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COMFORT+ — D.D.S., Inc. · Class II
PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
SHINING 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
Ori — ORI INC · Class II
R2i3 — Megagen Implant Co. Ltd · Class II

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: 3shape Trios A/S

Sources (1)

FDA UDI 14340faa-0ef0-4bf9-b7bc-39cf6d1760e7 35 fields · synced May 30, 2026