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Kera-Disc 99, 5 x 20 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref D10041210Ref D10041220Ref D10041108Ref D10041218Ref D10041216Ref D10041215Ref D10041224Ref 10041208
Identity
- Trade Name
- Kera-Disc EUDAMEDKera-Disc 99,5 x 20 mm FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Kera-Disc, Kera Line, Kera Soft-Disc EUDAMEDNEW - NPM - Cobalt-based dental alloy for milling, type 4, Dimension: 99,5 mm x 20 mm FDA UDI
- Model / Reference
- D10041210 EUDAMEDD10041220 EUDAMEDD10041108 EUDAMEDD10041218 EUDAMEDD10041216 EUDAMEDD10041215 EUDAMEDD10041224 EUDAMED10041208 EUDAMEDD10041120 FDA UDI
- Description
- NEW - NPM - Cobalt-based dental alloy for milling, type 4, Dimension: 99,5 mm x 20 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- ++EDWAD100412101 EUDAMED++EDWAD100412201 EUDAMED++EDWAD100411081 EUDAMED++EDWAD100412181 EUDAMED++EDWAD100412161 EUDAMED++EDWAD100412151 EUDAMED++EDWAD100412241 EUDAMED+EDWA100412081 EUDAMEDEDWAD100411201 FDA UDI
- Basic UDI-DI
- ++EDWACADCAMNEMQH EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
Yes
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental casting non-noble alloy
Kera-Disc 99, 5 x 20 mm by Eisenbacher Dentalwaren ED GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eisenbacher Dentalwaren ED GmbH
Sources (9)
- FDA UDI 0882414b-8ccf-4b45-9b18-7bd31b7fc390 33 fields · synced Jul 16, 2026
- EUDAMED 5a503369-ef3b-4621-839d-5343b266392d 61 fields · synced Jul 8, 2026
- EUDAMED c3b25c0e-6d7c-429f-81d0-4b8d8ac1d01f 61 fields · synced Jul 8, 2026
- EUDAMED ce3e2f46-17d7-47a2-a544-567c4a53f77a 61 fields · synced Jul 10, 2026
- EUDAMED b4299468-03c9-4364-9ffc-d95ffe05f138 61 fields · synced Jul 10, 2026
- EUDAMED 958ea645-5c74-414f-b7a0-beb4df257903 61 fields · synced Jul 10, 2026
- EUDAMED 0e875443-dee0-4c84-9be5-857324519e03 61 fields · synced Jul 13, 2026
- EUDAMED e661e923-b1ab-4d3e-8ddf-0e59849ca004 61 fields · synced Jul 16, 2026
- EUDAMED 8018c600-8dfe-4646-980d-96e59afca26e 61 fields · synced Jul 16, 2026