Identity
- Trade Name
- Juvora Ltd EUDAMEDCeramill PEEK by JUVORA™ Oyster White FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Juvora Dental discs EUDAMEDCERAMILL PEEK by JUVORA™ 760404, Oyster White 98x20 – 1 unit FDA UDI
- Model / Reference
- 760404 EUDAMEDFDA UDI
- Description
- CERAMILL PEEK by JUVORA™ 760404, Oyster White 98x20 – 1 unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055948229315 EUDAMEDFDA UDI
- Basic UDI-DI
- 50559482AAA0006C EUDAMED
- 510(k) Number
- K181331 FDA UDI
- FDA Product Code
- EBI FDA UDIEBG FDA UDIEBF FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3770 FDA UDI872.3690 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 98 Millimeter FDA UDIHeight — 20 Millimeter FDA UDI
Juvora Ltd by Juvora Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50559482AAA0006C | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Juvora Limited
- EUDAMED SRN
- GB-MF-000007895
- Authorised Representative
- Psephos Limited IE-AR-000003676
Sources (2)
- EUDAMED be984dd8-4c00-4862-8f37-be63b3442eb1 61 fields · synced Jul 25, 2026
- FDA UDI 6761f851-79bc-467c-babd-b1b725adceef 36 fields · synced May 30, 2026