Trios®

FDA UDI

Class II (US FDA UDI)

by 3shape Trios A/S

Identity

Trade Name: TRIOS® FDA UDI
Generic Name: Dental milling system, CAD/CAM, chairside FDA UDI
Device Name: Scanner tip (autoclavable) FDA UDI
Model / Reference: P12-tip FDA UDI
Description: Scanner tip (autoclavable) FDA UDI

Identifiers

Primary DI / UDI-DI: 05902729750103 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental milling system, CAD/CAM, chairside

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

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SHOFU DISK — SHOFU DENTAL CORP. · Class II
CS 3500 3D Scanner Collar — CARESTREAM HEALTH, INC. · Class II
DOA Kit, 5D US Plus — Align Technology, Inc. · Class II
KAVO X PRO REUSABLE TIP SUPPORT — PaloDEx Group Oy · 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 f8929da4-6d66-4d95-af49-4db651097a06 34 fields · synced Jun 8, 2026