Identity
- Trade Name
- Proxyt Medium 1x80 g EUDAMEDProxyt FDA UDI
- Generic Name
- Professional dental abrasive material FDA UDI
- Device Name
- Proxyt, VivaDent Polishing Paste EUDAMEDProxyt Medium 1x80 g FDA UDI
- Model / Reference
- 701471 EUDAMEDFDA UDI
- Description
- Proxyt Medium 1x80 g FDA UDI
Identifiers
- Catalog Number
- 701471 FDA UDI
- Primary DI / UDI-DI
- 07615208315608 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152081XPOLI0016E EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Professional dental abrasive material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Professional dental abrasive material
Proxyt by Ivoclar Vivadent Aktiengesellschaft — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 2b5fd1cf-406f-444f-969f-608e4cd31e66 34 fields · synced Jul 20, 2026
- EUDAMED 273db770-6bd2-4a50-b918-375cd5815e36 61 fields · synced Jul 20, 2026