Pulpdent Endodontic Post Cement Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962747 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Dental Cement, Endodontic (per FDA nomenclature), designed to secure endodontic posts within prepared root canals. It consists of a pre-packaged combination of materials used to bond posts to the dentin, ensuring stability during core build-up procedures in endodontic treatment.
The kit is intended for use in dental offices by trained professionals. Supplied as a single-use, non-sterile convenience package, it requires manual preparation and application. Compliance is established under FDA 510(k) clearance (K962747), classified as a Class II device under regulation 21 CFR 872.3275. No MRI safety or reusable components are specified.
Frequently asked questions
What is the primary purpose of the Pulpdent Endodontic Post Cement Kit in dental procedures?
The Pulpdent Endodontic Post Cement Kit is specifically designed to secure endodontic posts within prepared root canals during core build-up procedures in endodontic treatment. It bonds the posts to dentin, ensuring stability for long-term restoration.
Is the Pulpdent Endodontic Post Cement Kit sterile, and how is it supplied for use?
The kit is supplied as a non-sterile convenience package, intended for single-use. It requires manual preparation and application by trained dental professionals in-office, so sterilization is not included in the packaging.
Can this kit be reused, or is it meant for one-time use per patient?
The kit is explicitly labeled for single-use only. It is not designed for reuse, as it is intended to be manually prepared and applied per patient, ensuring hygiene and compliance with dental protocols.
What regulatory pathway was followed for FDA clearance of this device?
The Pulpdent Endodontic Post Cement Kit received FDA 510(k) clearance under the traditional review process, classified as a Class II device under regulation 21 CFR 872.3275. The clearance number is K962747, and it was determined to be *substantially equivalent* to a predicate device.
Does this kit include any reusable components, or is everything disposable?
The kit is entirely non-reusable—no components are specified for reuse. The materials are packaged for single-use convenience, requiring manual mixing and application by the clinician without any reusable tools or parts.
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 ENDODONTIC POST CEMENT KIT - Innolitics, PULPDENT ENDODONTIC POST CEMENT KIT by PULPDENT CORP. | FDA 510 (k) Summary, Cementation - PULPDENT, PULPDENT POST CEMENT (K020481) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962747 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K962747 24 fields · synced Sep 20, 2026