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Zolid gen-x B2 98x25

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 766877

by Amann Girrbach AG

Identity

Trade Name
Zolid gen-x B2 98x25 EUDAMED
Zolid FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
zirconia class 5 EUDAMED
Model / Reference
766877 EUDAMED
Zolid gen-x B2 98x25 FDA UDI

Identifiers

Catalog Number
766877 FDA UDI
Primary DI / UDI-DI
E4947668771 EUDAMEDFDA UDI
Basic UDI-DI
++E494ZIRKON5F5 EUDAMED
510(k) Number
K171876 FDA UDI
FDA Product Code
EIH FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Zolid gen-x B2 98x25 by Amann Girrbach AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amann Girrbach AG
EUDAMED SRN
AT-MF-000000252

Sources (3)

  • EUDAMED ab0393c7-36a6-48ed-8b55-f64c0e79f654 61 fields · synced Jun 20, 2026
  • FDA UDI 612aefd5-0f49-4113-9cee-8247797e86fc 35 fields · synced May 30, 2026
  • EUDAMED 771dbe9b-9ea0-4a80-8d99-837437bc3c60 61 fields · synced Jun 20, 2026