← Back to catalogue

ceraMotion®

FDA UDI

Class II (US FDA UDI)

by Dentaurum

Identity

Trade Name
ceraMotion® FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
ceraMotion® Zr Chroma Concept Set for extending the color space of standard and bleach materials/ For further information please visit our online-shop on www.dentaurum.de FDA UDI
Model / Reference
250-800-45 FDA UDI
Description
ceraMotion® Zr Chroma Concept Set for extending the color space of standard and bleach materials/ For further information please visit our online-shop on www.dentaurum.de FDA UDI

Identifiers

Primary DI / UDI-DI
J011250800450 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

ceraMotion® 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

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

Manufacturer

Manufacturer
Dentaurum

Sources (1)

  • FDA UDI b791b64e-cab8-4b33-8bc6-f6b746a3032d 37 fields · synced Jun 6, 2026