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3Shape Anatomy Design

FDA UDI

Class II (US FDA UDI)

by 3shape A/S

Identity

Trade Name
3Shape Anatomy Design FDA UDI
Generic Name
CAD/CAM software FDA UDI
Device Name
The Anatomy Design software is intended to be used for designing dental restorations for use by dentists for patients.The Anatomy Design software can be operated by trained dental practitioners and dental technicians.The Anatomy Design software is to be used in standard dentist clinics and dental laboratories FDA UDI
Model / Reference
2016-1 FDA UDI
Description
The Anatomy Design software is intended to be used for designing dental restorations for use by dentists for patients.The Anatomy Design software can be operated by trained dental practitioners and dental technicians.The Anatomy Design software is to be used in standard dentist clinics and dental laboratories FDA UDI

Identifiers

Primary DI / UDI-DI
05902768365115 FDA UDI
FDA Product Code
NOF FDA UDI
GMDN Term
CAD/CAM software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3661 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

3Shape Anatomy Design by 3shape A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3shape A/S

Sources (1)

  • FDA UDI 3186bd2f-0fb6-49fb-9b2e-90cbd5a14791 35 fields · synced Jun 6, 2026