NuCal Calcium Hydroxide Liner
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120003 FDA 510(k)
- FDA Product Code
- EJK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3250 FDA 510(k)
- Regulation Number
- 872.3250 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
NuCal is a Cavity Liner, Calcium Hydroxide (per FDA Product Code 76 EJK, 21 CFR Part 872.3250), a non-setting, radiopaque paste designed to protect dental pulp and promote healing. Its high pH (>12) provides antibacterial properties, making it suitable for direct application in prepared cavities or root canal spaces.
Supplied as a pre-mixed paste, NuCal is intended for single-use in dental procedures and is removed with water. It is packaged for sterile use and distributed under FDA 510(k) clearance (K120003) as a Class II device. No MRI safety or reusable indications are specified. Storage conditions are not detailed in the regulatory data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NUCAL (K120003) — FDA 510 (k) | Innolitics, PULPDENT ® Corporation - Advancing Dentistry Together, fda.innolitics.com, PDF 1 6002 - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120003 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K120003 24 fields · synced Sep 18, 2026