Identity
- Trade Name
- Herculite Ultra FDA UDI
- Generic Name
- Light-cured dental restorative composite resin FDA UDI
- Device Name
- Nanohybrid Composite Restorative; Syringe; Dentin A3.5; Refill FDA UDI
- Model / Reference
- 35626 FDA UDI
- Description
- Nanohybrid Composite Restorative; Syringe; Dentin A3.5; Refill FDA UDI
Identifiers
- Catalog Number
- 35626 FDA UDI
- Primary DI / UDI-DI
- 00841396104084 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Light-cured dental restorative composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4 Gram FDA UDI
Category: Light-cured dental restorative composite resin
Herculite Ultra by Kerr Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Light-cured dental restorative composite resin.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Kerr Corporation
Sources (1)
- FDA UDI 35226fda-0020-4da8-9404-077042201c9d 37 fields · synced Jun 8, 2026