Identity
- Trade Name
- SR Nexco Opaquer 2 ml C4 EUDAMEDSR Nexco FDA UDI
- Generic Name
- Dental prosthesis veneer resin FDA UDI
- Device Name
- SR Nexco, SR Link, SR Modelling Liquid EUDAMEDSR Nexco Opaquer 2 ml C4 FDA UDI
- Model / Reference
- 640442 EUDAMEDFDA UDI
- Description
- SR Nexco Opaquer 2 ml C4 FDA UDI
Identifiers
- Catalog Number
- 640442 FDA UDI
- Primary DI / UDI-DI
- 07615208006568 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACOMP004LJ EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental prosthesis veneer resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 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
Yes
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
No
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 prosthesis veneer resin
SR Nexco by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis veneer resin.
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- Solidex — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI aec1d209-3e56-45de-a28e-bb38e88b718e 34 fields · synced Jun 18, 2026
- EUDAMED 87c054e5-317a-4672-b1e9-b14f8d78b50d 61 fields · synced Jun 18, 2026