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Ionolux AC

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2123

by VOCO GmbH

Identity

Trade Name
Ionolux EUDAMED
Ionolux AC FDA UDI
Generic Name
Glass ionomer dental cement FDA UDI
Device Name
Ionolux EUDAMED
Light-curing glass ionomer restorativ material. FDA UDI
Model / Reference
2123 EUDAMEDFDA UDI
Description
Light-curing glass ionomer restorativ material. FDA UDI

Identifiers

Catalog Number
2123 FDA UDI
Primary DI / UDI-DI
E22121231 EUDAMEDFDA UDI
Basic UDI-DI
++E2210229000000000EE EUDAMED
FDA Product Code
EMA FDA UDI
EMDN Code
Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
GMDN Term
Glass ionomer dental cement FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3275 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

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

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VOCO GmbH

Sources (2)

  • FDA UDI 987d78f0-9e6d-477a-b31a-2f2d1db39f42 36 fields · synced Oct 7, 2026
  • EUDAMED c328e00f-b4b6-4494-b9c8-91f60c0cc749 61 fields · synced Jul 28, 2026