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Admira Bond

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2479Model bottle

by VOCO GmbH

Identity

Trade Name
Admira Bond EUDAMEDFDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Dentine adhesive FDA UDI
Device Name
Admira Bond EUDAMED
One-component dentine and enamel bond ORMOCER based. FDA UDI
Model / Reference
2479 EUDAMEDFDA UDI
bottle EUDAMED
2432 FDA UDI
Description
One-component dentine and enamel bond ORMOCER based. FDA UDI

Identifiers

Catalog Number
2432 FDA UDI
2479 FDA UDI
Primary DI / UDI-DI
E22124791 EUDAMEDFDA UDI
E22124321 FDA UDI
Basic UDI-DI
B-E22124791 EUDAMED
510(k) Number
K061823 FDA UDI
FDA Product Code
EBF FDA UDI
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED
GMDN Term
Dentine bonding agent/set FDA UDI
Dentine adhesive FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Market of Registration
Germany 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Category: Dentine bonding agent/set

Admira Bond by VOCO GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K061823 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
VOCO GmbH

Sources (3)

  • FDA UDI c82603bc-a853-4b74-aca7-37a67b5b0f1e 37 fields · synced Aug 5, 2026
  • FDA UDI 69776fda-a332-4cc1-9789-6088b1d8b056 37 fields · synced May 30, 2026
  • EUDAMED bcccb374-9b33-4f37-8930-65aae99fd8a5 61 fields · synced Aug 5, 2026