Identity
- Trade Name
- OVC3 One Visit Crown FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Packages contain x 6 matrix bands for upper molars 16.17 S (small), 16.17 M (medium), 16.17 L (large), 26.27 S (small), 26.27 M (medium), 26.27 L (large), x 6 matrix bands for lower molars 36.37 S (small), 36.37 M (medium), 36.37 L (large), 46.47 S (small), 46.47 M (medium), 46.47 L (large), x 16 stretch wedges FDA UDI
- Model / Reference
- OVC3 McDonald Matrix Band - Premolar Accessories Pack FDA UDI
- Description
- Packages contain x 6 matrix bands for upper molars 16.17 S (small), 16.17 M (medium), 16.17 L (large), 26.27 S (small), 26.27 M (medium), 26.27 L (large), x 6 matrix bands for lower molars 36.37 S (small), 36.37 M (medium), 36.37 L (large), 46.47 S (small), 46.47 M (medium), 46.47 L (large), x 16 stretch wedges FDA UDI
Identifiers
- Catalog Number
- 9421031795580 FDA UDI
- Primary DI / UDI-DI
- 09421031795580 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band, single-use
OVC3 One Visit Crown by Rhondium, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rhondium, Ltd.
Sources (1)
- FDA UDI f69ade7c-00de-4c52-aa99-0aaa11352dac 35 fields · synced May 30, 2026