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Pulpdent Glaze II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020514

by Pulpdent Corporation

Identifiers

510(k) Number
K020514 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)

Pulpdent Glaze II is a light-cured, unfilled resin dental material classified as an Agent, Tooth Bonding, Resin. It functions as a penetrating sealer and bonding agent for composite restorations and etched enamel, designed to reduce micro-leakage and marginal breakdown at restoration margins.

This material is intended for use by dental professionals in a clinical setting. Supplied as a single-use product, it is applied directly to composite surfaces and cured under light. The device is regulated under FDA 510(k) clearance (K020514) and falls under regulation number 872.3200, with a classification as a Class II medical device. No specific sterility or MRI safety information is provided.

Frequently asked questions

What is Pulpdent Glaze II used for in a clinical setting?

Pulpdent Glaze II is a light-cured, unfilled resin designed specifically as a penetrating sealer and bonding agent for composite restorations and etched enamel. Its primary purpose is to reduce micro-leakage and marginal breakdown at the restoration margins, helping to improve the longevity and seal of dental fillings.

Is Pulpdent Glaze II intended for single-use or can it be reused?

Pulpdent Glaze II is explicitly supplied as a single-use product. This means each application requires a new unit, ensuring sterility and preventing cross-contamination in clinical settings.

How is Pulpdent Glaze II applied in a dental procedure?

Pulpdent Glaze II is applied directly to composite surfaces in a clinical setting and then cured under light. The light-curing process activates the resin, allowing it to bond effectively and penetrate the etched enamel or composite restoration.

What regulatory pathway does Pulpdent Glaze II follow, and what does that mean for its use?

Pulpdent Glaze II follows the FDA 510(k) clearance pathway, classified as a Class II medical device under regulation number 872.3200. This means it has been determined to be substantially equivalent to a legally marketed device and is regulated as a dental agent for tooth bonding, ensuring it meets specific safety and performance standards for clinical 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 GLAZE II (K020514) — FDA 510 (k) | Innolitics, PULPDENT GLAZE II 510 (k) K020514 - FDA.report, PULPDENT GLAZE (K020432) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K020514 24 fields · synced Sep 18, 2026