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Admira

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2420Model syringe

by VOCO GmbH

Identity

Trade Name
Admira EUDAMEDFDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Admira EUDAMED
Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (ormocers). Admira is suitable for restorations in both anterior and posterior teeth. This is a kit of 7 syringes. FDA UDI
Model / Reference
2420 EUDAMEDFDA UDI
syringe EUDAMED
Description
Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (ormocers). Admira is suitable for restorations in both anterior and posterior teeth. This is a kit of 7 syringes. FDA UDI

Identifiers

Catalog Number
2420 FDA UDI
Primary DI / UDI-DI
E22124201 EUDAMEDFDA UDI
Basic UDI-DI
B-E22124201 EUDAMED
510(k) Number
K061823 FDA UDI
FDA Product Code
EBF FDA UDI
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
GMDN Term
Dental composite resin 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

Yes

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

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

Cleared under the same submission

K061823 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VOCO GmbH

Sources (2)

  • FDA UDI f91b8654-8c6c-4962-8f7a-81ad3f9c7036 37 fields · synced Oct 7, 2026
  • EUDAMED 29a6ec54-518d-4d64-87bc-b4631ea69872 61 fields · synced Jul 9, 2026