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HIRO Light Cure Pattern, Modeling and Indexing Resin
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- HIRO Light Cure Pattern, Modeling and Indexing Resin FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Device Name
- Light Cure Pattern, Modeling and Indexing Resin. FDA UDI
- Model / Reference
- One 3 mL Syringe FDA UDI
- Description
- Light Cure Pattern, Modeling and Indexing Resin. FDA UDI
Identifiers
- Catalog Number
- HIRO FDA UDI
- Primary DI / UDI-DI
- D820HIRO0 FDA UDI
- FDA Product Code
- EKO FDA UDI
- GMDN Term
- Dental prosthesis restorative material, unfilled resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3600 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HIRO Light Cure Pattern, Modeling and Indexing Resin by Denali Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Denali Corporation
Sources (1)
- FDA UDI 83dfed49-a954-4edf-9989-c13af179e1b2 35 fields · synced Jun 6, 2026