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Ceramill A-Temp A3.5 98x20

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 761361510(k) K191843

by Amann Girrbach AG

Identity

Trade Name
Ceramill A-Temp A3.5 98x20 EUDAMED
Ceramill FDA UDI
Generic Name
Temporary dental crown/bridge FDA UDI
Device Name
Polymers temporary / Kunststoffe temporär EUDAMED
Model / Reference
761361 EUDAMED
A-Temp A3,5 98x20 FDA UDI

Identifiers

Catalog Number
761361 FDA UDI
Primary DI / UDI-DI
E4947613611 EUDAMEDFDA UDI
Basic UDI-DI
++E494ATEMPML3Q EUDAMED
510(k) Number
K191843 FDA UDI
FDA Product Code
POW FDA UDI
EBG FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Temporary dental crown/bridge FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3770 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

Ceramill A-Temp A3.5 98x20 by Amann Girrbach AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Amann Girrbach AG
EUDAMED SRN
AT-MF-000000252

Sources (3)

  • EUDAMED 13c1f7ab-2e11-4892-b862-2cf613f9597a 85 fields · synced Jun 18, 2026
  • FDA UDI 5c2f29a6-1fd8-4a53-b12f-38a3ff08b0c4 34 fields · synced May 30, 2026
  • FDA 510(k) K191843 1 fields · synced May 19, 2026