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Pulpdent Glaze

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020432

by Pulpdent Corporation

Identifiers

510(k) Number
K020432 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pulpdent Glaze is a dental material classified under the product code EBF, intended for use in dental restorative procedures. It is designed to provide a smooth, glossy finish to dental restorations, enhancing aesthetics and durability.

This product is supplied as a single-use item and has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device. It is manufactured by Pulpdent Corporation in Watertown, Massachusetts, and is intended for use in dental offices under sterile conditions.

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 ® Corporation - Advancing Dentistry Together, Pulpdent: About Us, Pulpdent - LinkedIn, Pulpdent Corporation Company Profile | Watertown, Massachusetts ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K020432 24 fields · synced Sep 18, 2026