Identity
- Trade Name
- Core Forms FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Core Forms EUDAMEDBox of 64 – x-large FDA UDI
- Model / Reference
- HCF-4 EUDAMEDFDA UDI
- Description
- Box of 64 – x-large FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701HCF42 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D701HCFPX EUDAMED
- Unit of Use DI
- 1 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q01010203 DENTAL CONES EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic gutta-percha
Core Forms by Pulpdent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic gutta-percha.
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- EdgeSequel™ — US Endodontics, LLC · Class I
- Gutta Percha Points — TULSA DENTAL PRODUCTS LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701HCFPX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 04f31926-6ee2-48b4-93e1-65e7d862293d 61 fields · synced Jul 12, 2026
- FDA UDI be1a5831-58ca-40ce-aa45-286d8de86d34 33 fields · synced May 30, 2026