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Solobond M

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 1225510(k) K980539Ref 1227Ref 1226

by VOCO GmbH

Identity

Trade Name
Solobond M EUDAMED
Device Name
Solobond M EUDAMED
Model / Reference
1225 EUDAMED
1227 EUDAMED
1226 EUDAMED

Identifiers

Primary DI / UDI-DI
E22112251 EUDAMED
E22112271 EUDAMED
E22112261 EUDAMED
Basic UDI-DI
++E2210632000000000DN EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Category: Dentine bonding agent/set

Solobond M by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
VOCO GmbH
EUDAMED SRN
DE-MF-000008601

Sources (4)

  • EUDAMED 55acb5a8-5fb5-4627-8aad-a8153467703d 85 fields · synced Oct 6, 2026
  • EUDAMED fff8fb8e-6684-4a1c-8172-2dab7685c40a 61 fields · synced Jul 11, 2026
  • EUDAMED cfdcdf20-0508-4155-8358-69030a764ce8 61 fields · synced Jul 13, 2026
  • FDA 510(k) K980539 1 fields · synced May 18, 2026