Ionoseal

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 1126510(k) K912495Ref 1128Ref 1326

by VOCO GmbH

Identity

Trade Name: Ionoseal EUDAMEDFDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: Ionoseal EUDAMED
Dual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set. FDA UDI
Light-curing glass ionomer composite liner. FDA UDI
Model / Reference: 1126 EUDAMEDFDA UDI
1326 EUDAMEDFDA UDI
1128 EUDAMED
Description: Dual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set. FDA UDI
Light-curing glass ionomer composite liner. FDA UDI

Identifiers

Catalog Number: 1326 FDA UDI
1126 FDA UDI
Primary DI / UDI-DI: E22111261 EUDAMEDFDA UDI
E22113261 EUDAMEDFDA UDI
E22111281 EUDAMED
Basic UDI-DI: ++E2210660000000000ER EUDAMED
FDA Product Code: EJK FDA UDI
EMDN Code: Q0101010201 DENTAL BASE CEMENTS EUDAMED
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.3250 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

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

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Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K912495	Class IIa	Active
EUDAMED	European Union	CE/MDR	++E2210660000000000ER	Class IIa	Active

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Manufacturer

Manufacturer: VOCO GmbH
EUDAMED SRN: DE-MF-000008601

Sources (6)

EUDAMED e62d21f7-d48a-474b-9363-1a0a26bccb6e 85 fields · synced Jul 18, 2026
FDA UDI 6d9ac9f8-2c72-465b-a146-6418b0ece09e 36 fields · synced May 29, 2026
FDA UDI d2991f27-f795-4ec2-a72c-9d6aaceffd0f 36 fields · synced May 30, 2026
EUDAMED 53f2eea1-b9f9-4a6a-ba06-3c89a55b9f5a 61 fields · synced Jul 16, 2026
EUDAMED 9a9a7142-178d-4c08-8112-2e118a074ab9 61 fields · synced Jul 18, 2026
FDA 510(k) K912495 1 fields · synced May 18, 2026