Identity
- Trade Name
- Universal Transfer Bow System 3D EUDAMEDUTS 3D/ UTS CAD FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- UTS 3D, UTS CAD EUDAMEDUniversal Transfer Bow System 3D FDA UDI
- Model / Reference
- 593710 EUDAMEDFDA UDI
- Description
- Universal Transfer Bow System 3D FDA UDI
Identifiers
- Catalog Number
- 593710 FDA UDI
- Primary DI / UDI-DI
- 07615208460483 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152081XBITE003WF EUDAMED
- FDA Product Code
- KCR FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3220 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Facebow
Uts 3d/ Uts Cad by Ivoclar Vivadent Aktiengesellschaft — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Facebow.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI 1fb2480a-e2cf-4bb3-8f81-7b8990a71ace 34 fields · synced Jul 12, 2026
- EUDAMED 85d72105-e902-4033-a1ea-d404a4cae328 61 fields · synced Jul 12, 2026