Identity
- Trade Name
- SR Ivolen FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- SR Ivolen Powder 2x500 g FDA UDI
- Model / Reference
- 530363 FDA UDI
- Description
- SR Ivolen Powder 2x500 g FDA UDI
Identifiers
- Catalog Number
- 530363 FDA UDI
- Primary DI / UDI-DI
- DIVO5303631 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression tray material
SR Ivolen by Ivoclar Vivadent Aktiengesellschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray material.
- Eazipan LC — VERICOM CO., LTD. · Class I
- INSTANT TRAY MIX POWDER — Lang Dental Manufacturing Company, Inc. · Class I
- Vitacrilic® — FRICKE INTERNATIONAL, INC. · Class I
- Premium Tray — Denplus Inc · Class I
- Bosworth Fastray LC — Harry J. Bosworth Co. · Class II
- OpaTray — OPA DENTAL, LLC · Class I
- DURALAY - BLUE — Reliance Dental Manufacturing · Class I
- JET TRAY POWDER — Lang Dental Manufacturing Company, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI 8f44754b-d97d-4a76-9c29-4ae384418817 34 fields · synced May 30, 2026