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Carmen®

FDA UDI

Class II (US FDA UDI)

by Dentaurum

Identity

Trade Name
Carmen® FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Carmen® Combination Set / Carmen® is a dental ceramic material / For further information please visit our online-shop on our website www.dentaurum.de FDA UDI
Model / Reference
260-116-00 FDA UDI
Description
Carmen® Combination Set / Carmen® is a dental ceramic material / For further information please visit our online-shop on our website www.dentaurum.de FDA UDI

Identifiers

Primary DI / UDI-DI
J011260116000 FDA UDI
510(k) Number
K011425 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Carmen® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K011425 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentaurum

Sources (1)

  • FDA UDI acbef8b3-0c97-4be4-8974-129d2f3dfdcd 37 fields · synced Jun 1, 2026