← Back to catalogue

Ceramill Zolid FX ML A2/A3 98x20 F

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 767638

by Amann Girrbach AG

Identity

Trade Name
Ceramill Zolid FX ML A2/A3 98x20 F EUDAMED
Ceramill FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
zirconia class 4 EUDAMED
Model / Reference
767638 EUDAMED
Ceramill Zolid FX ML A2/A3 98x20 F FDA UDI

Identifiers

Catalog Number
767638 FDA UDI
Primary DI / UDI-DI
E4947676381 EUDAMEDFDA UDI
Basic UDI-DI
++E494ZIRKON4F3 EUDAMED
510(k) Number
K152383 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ceramill Zolid FX ML A2/A3 98x20 F 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

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

Manufacturer

Manufacturer
Amann Girrbach AG
EUDAMED SRN
AT-MF-000000252

Sources (2)

  • EUDAMED a3932aa9-206a-4dbc-ab23-f162e50b498b 61 fields · synced Jul 30, 2026
  • FDA UDI 818d1c4f-d72c-4eb1-9020-fbdbbb8aaa3d 35 fields · synced May 30, 2026