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Multilink Automix / Primer A+B

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 613627WW

by Ivoclar Vivadent Aktiengesellschaft

Identity

Trade Name
Multilink Primer Refill B 3 g EUDAMED
Multilink Automix / Primer A+B FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Multilink Automix / Primer A+B, Multilink N, Variolink Esthetic, Variolink 100, Variolink N, Variolink N-Esthetic DC EUDAMED
Multilink Primer Refill B 3 g FDA UDI
Model / Reference
613627WW EUDAMEDFDA UDI
Description
Multilink Primer Refill B 3 g FDA UDI

Identifiers

Catalog Number
613627WW FDA UDI
Primary DI / UDI-DI
07615208298659 EUDAMEDFDA UDI
Basic UDI-DI
76152082ACEME001DV EUDAMED
FDA Product Code
EMA FDA UDI
EMDN Code
Q0101010201 DENTAL BASE CEMENTS EUDAMED
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3275 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: Dentine bonding agent/set

Multilink Automix / Primer A+B by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ivoclar Vivadent Aktiengesellschaft

Sources (2)

  • FDA UDI d6abfe71-04ba-439f-9256-c1a9693dc796 34 fields · synced Jul 10, 2026
  • EUDAMED b636c404-61da-4c4a-9785-852907dd732b 61 fields · synced Jul 10, 2026