Identity
- Trade Name
- myHoopy Wedge Blue, Xtra Large (XL) 100 EUDAMEDOVC Lithium FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Separator Wedge EUDAMEDPackage contains an OVC Lithium for tooth number FDI 46.47 : USA 30-31 in shade A2 and size L (Large), 4 x OVC Wedges, 1 x Selector Key, 1 x OVC Matrix Band and 1 x OVC Lithium Replica. FDA UDI
- Model / Reference
- 7605 EUDAMEDOVC Lithium FDI 46.47 L : USA 30-31 L A2 FDA UDI
- Description
- Package contains an OVC Lithium for tooth number FDI 46.47 : USA 30-31 in shade A2 and size L (Large), 4 x OVC Wedges, 1 x Selector Key, 1 x OVC Matrix Band and 1 x OVC Lithium Replica. FDA UDI
Identifiers
- Catalog Number
- 84642161120 FDA UDI
- Primary DI / UDI-DI
- 09421031791834 EUDAMEDFDA UDI
- Basic UDI-DI
- 942103179RLW0001E2 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
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
No
FDA UDI
OVC Lithium by Rhondium, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Rhondium, Ltd.
Sources (2)
- FDA UDI 697e9d44-dfc4-45e6-8b8c-07351eb40d86 38 fields · synced Jul 30, 2026
- EUDAMED 3aae3dab-9449-4672-90ff-16bd8f7f34b8 61 fields · synced Jul 30, 2026