Identity
- Trade Name
- SR Link 5 ml EUDAMEDSR Link FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- SR Nexco, SR Link, SR Modelling Liquid EUDAMEDSR Link 5 ml FDA UDI
- Model / Reference
- 545872 EUDAMEDFDA UDI
- Description
- SR Link 5 ml FDA UDI
Identifiers
- Catalog Number
- 545872 FDA UDI
- Primary DI / UDI-DI
- 07615208406146 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 priming agent 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 priming agent
SR Link 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 priming agent.
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- 3Delta Denture Bond — DeltaMed GmbH · Class II
- CLEARFIL™ PORCELAIN BOND ACTIVATOR — KURARAY NORITAKE DENTAL INC. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · 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 15ae7ffa-cb4a-41ad-b665-3df470ce1446 34 fields · synced Jun 18, 2026
- EUDAMED a94f9873-c8e9-49d8-9718-520e25873acc 61 fields · synced Jun 18, 2026