Identity
- Trade Name
- PULPDENT® CAVITY LINER FDA UDI
- Generic Name
- Calcium hydroxide dental suspension FDA UDI
- Device Name
- 15 mL bottle FDA UDI
- Model / Reference
- PCL FDA UDI
- Description
- 15 mL bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701PCL2 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Calcium hydroxide dental suspension 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
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
Category: Calcium hydroxide dental suspension
Pulpdent® Cavity Liner by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium hydroxide dental suspension.
- UltraCal XS — ULTRADENT PRODUCTS, INC. · Class II
- UltraCal XS — ULTRADENT PRODUCTS, INC. · Class II
- Centrix Endo Kit — CENTRIX, INC. · Class II
- Calciject — CENTRIX, INC. · Class II
- UltraCal XS — ULTRADENT PRODUCTS, INC. · Class II
- UltraCal XS — ULTRADENT PRODUCTS, INC. · Class II
- UltraCal XS — ULTRADENT PRODUCTS, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI 03d35a4b-e6d3-464e-a016-810f18e2f64e 33 fields · synced Jun 9, 2026