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Juvora Ltd
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 760403Ref DD-98-22-02 Oyster White
Identity
- Trade Name
- Juvora Ltd EUDAMEDJUVORA™ Oyster White Dental Disc FDA UDICeramill PEEK by JUVORA™ Oyster White FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Juvora Dental discs EUDAMEDJUVORA™ Oyster White Dental Disc - 98mm x 22mm 1 unit FDA UDICERAMILL PEEK by JUVORA™ 760403, Oyster White 98x12 – 1 unit FDA UDI
- Model / Reference
- 760403 EUDAMEDFDA UDIDD-98-22-02 Oyster White EUDAMED540106 FDA UDI
- Description
- JUVORA™ Oyster White Dental Disc - 98mm x 22mm 1 unit FDA UDICERAMILL PEEK by JUVORA™ 760403, Oyster White 98x12 – 1 unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055948229308 EUDAMEDFDA UDI05055948229643 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
- Height — 22 Millimeter FDA UDIOuter Diameter — 98 Millimeter FDA UDIHeight — 12 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European Union No Longer Active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 (4)
- EUDAMED bc09124c-2d3f-4c2d-b6b6-1e167b42ee80 61 fields · synced Jul 12, 2026
- FDA UDI 4e3e248a-4d8b-4a19-b787-1279cdbf9379 36 fields · synced May 30, 2026
- FDA UDI 87055f6b-78c9-450b-86e8-6cf2648c5942 36 fields · synced May 30, 2026
- EUDAMED 218a0e9d-7e1a-471a-9d1a-6911f7011564 61 fields · synced Jul 12, 2026