Identifiers
- 510(k) Number
- K040599 FDA 510(k)
- FDA Product Code
- EBD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3310 FDA 510(k)
- Regulation Number
- 872.3310 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Parkell Resin Glaze is a coating, filling material, resin classified under product code EBD. It is a nano-filled, light-cured, clear resin applied by dental professionals to composite resin restorations or temporary dental materials such as acrylic or bis-acryl.
The material is applied to the surface of the restoration and cured using a light source. It creates a surface seal and high-sheen finish without oxygen-inhibition, enhancing the durability of the restoration. It is supplied as a dental device for professional use and received FDA 510(k) clearance (K040599) on April 9, 2004, classified as Class II with special controls.
Frequently asked questions
What is Parkell Resin Glaze used for?
Parkell Resin Glaze is used by dental professionals as a coating and filling material applied to the surface of composite resin restorations or temporary dental materials like acrylic or bis-acryl to create a surface seal and high-sheen finish, enhancing restoration durability.
How is Parkell Resin Glaze applied and cured?
Parkell Resin Glaze is applied to the surface of a dental restoration and then cured using a light source, which triggers polymerization without oxygen inhibition, resulting in a durable, glossy surface.
Is Parkell Resin Glaze a single-use or reusable device?
Parkell Resin Glaze is supplied as a dental device for professional use and is intended for single-patient application; the material is dispensed and used per restoration, making it effectively single-use in clinical practice.
What are the storage and handling requirements for Parkell Resin Glaze?
As a light-cured resin, Parkell Resin Glaze must be stored away from direct light and heat to prevent premature curing; specific storage conditions should follow the manufacturer’s labeling to maintain material integrity and shelf life.
What regulatory pathway was used for Parkell Resin Glaze?
Parkell Resin Glaze received FDA 510(k) clearance (K040599) on April 9, 2004, and is classified as a Class II medical device with special controls under product code EBD for coating, filling material, resin.
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: K040599 - PARKELL RESIN GLAZE | FDA 510 (k) | Parkell, Inc., PARKELL RESIN GLAZE (K040599) — FDA 510 (k) | Innolitics, Parkell FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040599 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA 510(k) K040599 24 fields · synced Sep 26, 2026