Identity
- Trade Name
- SR Ivolen Powder 2x500 g EUDAMEDSR Ivolen FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- SR Ivolen EUDAMEDSR Ivolen Powder 2x500 g FDA UDI
- Model / Reference
- 530363 EUDAMEDFDA UDI
- Description
- SR Ivolen Powder 2x500 g FDA UDI
Identifiers
- Catalog Number
- 530363 FDA UDI
- Primary DI / UDI-DI
- 07615208421071 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152081XTRAY0039L EUDAMED
- Unit of Use DI
- 07615208455120 EUDAMED
- FDA Product Code
- EBH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3670 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: Dental impression tray material
SR Ivolen by Ivoclar Vivadent Aktiengesellschaft — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray material.
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- JET TRAY POWDER — Lang Dental Manufacturing Company, Inc. · Class I
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 c57f4ca1-9be8-4eb8-b826-6f3a2fdad7d4 34 fields · synced Jul 11, 2026
- EUDAMED adf647ab-6b92-4e1d-867d-b7a197bd28a3 61 fields · synced Jul 11, 2026