Identity
- Trade Name
- OVC3 One Visit Crown FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Packages contain x6 matrix bands for upper premolars 14.15 S (small), 14.15 M (medium), 14.15 L (large), 24.25 S (small), 24.25 M (medium), 24.25 L (large), x6 matrix bands for lower premolars 34.35 S (small), 34.35 M (medium), 34.35 L (large), 44.45 S (small), 44.45 M (medium), 44.45 L (large), x 16 stretch wedges FDA UDI
- Model / Reference
- OVC3 McDonald Matrix Band - Premolar Accessories Pack FDA UDI
- Description
- Packages contain x6 matrix bands for upper premolars 14.15 S (small), 14.15 M (medium), 14.15 L (large), 24.25 S (small), 24.25 M (medium), 24.25 L (large), x6 matrix bands for lower premolars 34.35 S (small), 34.35 M (medium), 34.35 L (large), 44.45 S (small), 44.45 M (medium), 44.45 L (large), x 16 stretch wedges FDA UDI
Identifiers
- Catalog Number
- 9421031795573 FDA UDI
- Primary DI / UDI-DI
- 09421031795573 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 5c44fb83-7914-41d8-9b33-ad515982e4cc 35 fields · synced Jun 1, 2026