Identity
- Trade Name
- Pulpdent® Paste FDA UDI
- Generic Name
- Dental pulp-capping material FDA UDI
- Device Name
- KIT: 3 mL syringe with 24 needles (18 gauge blunt) -Calcium Hydroxide Paste, Radiopaque FDA UDI
- Model / Reference
- PSYK FDA UDI
- Description
- KIT: 3 mL syringe with 24 needles (18 gauge blunt) -Calcium Hydroxide Paste, Radiopaque FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701PSYK2 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Dental pulp-capping material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 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
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
Category: Dental pulp-capping material
Pulpdent® Paste by Pulpdent Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI 06e7b7ca-4814-4779-a31a-8eaefbfcbebe 33 fields · synced Jun 9, 2026