Identity
- Trade Name
- ACTIVA TM BioACTIVE- BASE/LINER FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- SINGLE PACK: 5mL/7gm syringe + 20 automix tips FDA UDI
- Model / Reference
- VB1 FDA UDI
- Description
- SINGLE PACK: 5mL/7gm syringe + 20 automix tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701VB12 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Calcium hydroxide dental cement 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: Calcium hydroxide dental cement
ACTIVA TM BioACTIVE- BASE/LINER 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 ff2a9278-af19-460f-af5a-29d40632c4fe 33 fields · synced Jun 9, 2026