Pulpdent Glass Ionomer Cements
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K952854 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Glass Ionomer Cement is a dental adhesive material classified as a glass ionomer, designed for bonding to metal bands, enamel, and dentin. It functions as a restorative and luting agent, providing radiopacity and fluoride release to strengthen tooth structure and support orthodontic or restorative procedures.
Supplied as a self-cure powder-liquid system, this cement is intended for single-use applications in dental settings. It requires mixing on-site and is regulated under FDA 510(k) clearance (K952854) as a Class II device (DYH product code). Sterility is not specified, and compatibility with MRI is not indicated. Sizes include a 30 g powder and 15 mL liquid, packaged with mixing tools.
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: Glass Ionomer Band Cement - PULPDENT, GlassLute™ - PULPDENT, Ortho-Choice OCGI Glass Ionomer Orthodontic Band Cement, Pulpdent Ortho-Choice Glass Ionomer Band Cement Set | OCGI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K952854 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K952854 24 fields · synced Sep 20, 2026