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Pulpdent Post Cement

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952960

by Pulpdent Corporation

Identifiers

510(k) Number
K952960 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)

Pulpdent Post Cement is a Dental Cement designed for bonding dental restorations. It functions as a fluoride-releasing, dual-cure resin cement, providing mechanical retention and chemical adhesion for permanent cementation of posts, crowns, inlays, onlays, bridges, veneers, splints, and bonded amalgam techniques.

This device is supplied as a single-use dental adhesive intended for use in clinical settings by licensed dental practitioners. It is not sterile but requires proper handling and storage as per manufacturer guidelines. The product is classified under FDA Device Class II (872.3275) and holds a 510(k) clearance for dental applications. No MRI safety information is specified.

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: Cementation - PULPDENT, PULPDENT POST CEMENT (K020481) — FDA 510(k) | Innolitics, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ..., Pulpdent | Cargus International Dental Supplies

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K952960 24 fields · synced Sep 20, 2026