Elite HD+ Maxi Tray Material Fast Set
FDA UDIEUDAMEDClass II (US FDA UDI)
by Zhermack Spa
Identity
- Trade Name
- Elite HD+ Maxi Tray Material Fast Set EUDAMEDFDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- VPS0 EUDAMEDAddition silicone impression material FDA UDI
- Model / Reference
- C202330 EUDAMEDFDA UDI
- Description
- Addition silicone impression material FDA UDI
Identifiers
- Catalog Number
- C202330 FDA UDI
- Primary DI / UDI-DI
- 08056000371413 EUDAMEDEZHIC2023301 FDA UDI
- Basic UDI-DI
- 805600037VPS0BD EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 2280 Milliliter FDA UDI
Category: Silicone dental impression material
Elite HD+ Maxi Tray Material Fast Set by Zhermack Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zhermack Spa
Sources (2)
- FDA UDI 3c202d23-2b80-4824-8dc0-57d99cae6bcc 36 fields · synced Aug 1, 2026
- EUDAMED 8a1c361f-ba20-4edd-a01f-bc51275293be 61 fields · synced Aug 1, 2026