Identity
- Trade Name
- HARDCORE® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas FDA UDI
- Model / Reference
- HC FDA UDI
- Description
- CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701HC2 FDA UDI
- 510(k) Number
- K922755 FDA UDI
- FDA Product Code
- EMA FDA UDIEBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI872.3690 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 20 Gram FDA UDI
Hardcore® by Pulpdent 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
- Pulpdent Corporation
Sources (1)
- FDA UDI 13def9e3-a3d7-4078-8de4-7318389e796c 36 fields · synced Jun 9, 2026