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3Shape Scan Bodies

FDA UDI

Class I (US FDA UDI)

by 3shape Trios A/S

Identity

Trade Name
3Shape Scan Bodies FDA UDI
Generic Name
Dental milling system, CAD/CAM, laboratory FDA UDI
Device Name
XiVE - Narrow platform - Connection: 3,0 FDA UDI
Model / Reference
DX3 FDA UDI
Description
XiVE - Narrow platform - Connection: 3,0 FDA UDI

Identifiers

Primary DI / UDI-DI
05902729751605 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental milling system, CAD/CAM, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.0 Millimeter FDA UDI

Category: Dental milling system, CAD/CAM, laboratory

3Shape Scan Bodies by 3shape Trios A/S — Class I — 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
3shape Trios A/S

Sources (1)

  • FDA UDI 81829e44-18e5-4833-9ae2-5bfe2ace204e 35 fields · synced May 30, 2026