Pulpdent Calcium Hydroxide Preparations
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K944945 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)
This device is a Liner, Cavity, Calcium Hydroxide, classified as a Class II dental product. It is a calcium hydroxide-based preparation designed for use in endodontic procedures, including root canal therapy and vital pulp therapy, to promote tissue healing and protect dental pulp.
The preparations are supplied as single-use, non-sterile pastes or creams for clinical application in dental settings. They are intended for intracanal dressings, treatment of abscesses, cysts, periapical lesions, root resorption, and root fractures. Authorized under FDA 510K clearance (K944945), these products adhere to dental regulatory standards for use in root canal and pulp therapy applications.
Frequently asked questions
Are these calcium hydroxide preparations meant for repeated use in the same patient, or are they single-use only?
These preparations are explicitly labeled as single-use pastes or creams. They are designed for one-time clinical application in endodontic procedures, such as root canal therapy or vital pulp therapy, to avoid contamination or degradation between uses.
What specific dental conditions are these calcium hydroxide preparations intended to address during endodontic procedures?
The preparations are intended for intracanal dressings and treating conditions like abscesses, cysts, periapical lesions, root resorption, and root fractures. They promote tissue healing and protect dental pulp during procedures such as root canal therapy and vital pulp therapy.
How are these products supplied, and do they require any special handling before use?
They are supplied as non-sterile pastes or creams in single-use formats, meaning they are pre-packaged for immediate clinical application. Since they are non-sterile, they should be handled in a manner that maintains aseptic technique during dental procedures, such as using sterile instruments for application.
What regulatory pathway was followed for FDA clearance of these calcium hydroxide preparations?
The device was cleared through the FDA 510(k) pathway, specifically under Traditional Review by the Dental (DE) Advisory Committee. The clearance (K944945) was granted in 1994 and classified as Substantially Equivalent (SESE) to a predicate device, adhering to dental regulatory standards for endodontic use.
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: Pulpdent® Paste - PULPDENT, Multi-Cal™ - PULPDENT, Multi-Cal ™ (Pulpdent) | Pearson Dental, Multi-Cal: Calcium Hydroxide Paste (4x1.2 ml) - PULPDENT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944945 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K944945 24 fields · synced Sep 18, 2026