Identity
- Trade Name
- Variolink Esth. DC Refill 3x9g warm EUDAMEDVariolink Esthetic FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Multilink Automix / Primer A+B, Multilink N, Variolink Esthetic, Variolink 100, Variolink N, Variolink N-Esthetic DC EUDAMEDVariolink Esth. DC Refill 3x9g warm FDA UDI
- Model / Reference
- 692426WW EUDAMEDFDA UDI
- Description
- Variolink Esth. DC Refill 3x9g warm FDA UDI
Identifiers
- Catalog Number
- 692426WW FDA UDI
- Primary DI / UDI-DI
- 07615208293449 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACEME001DV EUDAMED
- Unit of Use DI
- 07615208460889 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
- GMDN Term
- Dental composite 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 composite resin
Variolink Esthetic by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · 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 b2e86450-42f0-4784-9acb-aa82081e6167 34 fields · synced Aug 2, 2026
- EUDAMED 716c16b1-fb11-4e6b-afcf-cfe222e837b5 61 fields · synced Aug 2, 2026