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Pulpdent Unfilled Dual Cure Bonding Resin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K930989

by Pulpdent Corporation

Identifiers

510(k) Number
K930989 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Tooth Bonding Resin, classified as an Agent under FDA nomenclature. It is an unfilled, dual-cure resin intended for bonding dental restorations to tooth structure. The resin provides mechanical retention by bonding to dentin, enamel, and other substrates, ensuring durable adhesion for fillings, crowns, or other restorative materials.

The Pulpdent Unfilled Dual Cure Bonding Resin is supplied as a liquid resin for manual application in dental settings. It is intended for single-use and requires proper handling to maintain sterility. The device is FDA-cleared under 510(k) classification (K945112) and adheres to dental regulatory standards (regulation number 872.3200). No MRI safety or reusable specifications are noted in the 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: DenTASTIC® UNO™-DUO™ - PULPDENT, PULPDENT DUAL CURE UNFILLED BONDING RESIN (K945112) — FDA 510(k ..., DenTASTIC® All Purpose - PULPDENT, PULPDENT DUAL CURE UNFILLED BONDING RESIN 510(k)… - FDA.report

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) K930989 24 fields · synced Sep 20, 2026