Identity
- Trade Name
- DME Wedge Intro Pack EUDAMEDOVC™ One Visit Crown FDA UDI
- Generic Name
- Preformed dental crown, permanent FDA UDI
- Device Name
- DME Wedge EUDAMEDPackage contains an OVC for tooth number 18 or 19, in shade A2 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica FDA UDI
- Model / Reference
- 09421031790271 EUDAMEDOVC 18-19 XL A2 FDA UDI
- Description
- Package contains an OVC for tooth number 18 or 19, in shade A2 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421031790271 EUDAMEDFDA UDI
- Basic UDI-DI
- 942103179RLDME00013W EUDAMED
- 510(k) Number
- K143694 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Preformed dental crown, permanent FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 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™ One Visit Crown by Rhondium, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K143694 also covers:
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
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 5b9171b4-99ee-4ed1-9602-d372698597ce 38 fields · synced Jul 24, 2026
- EUDAMED 908aa897-e592-4703-83bd-a2a3ddcd2f29 61 fields · synced Jul 24, 2026