Pulpdent Glass Ionomer Cement
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951270 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A dental glass ionomer cement designed for bonding to metal bands, enamel, and dentin. These cements are self-curing, radiopaque materials used primarily in orthodontic and restorative procedures to provide durable adhesion and fluoride release for long-term stability.
Supplied as powder-liquid kits, these cements are intended for single-use in clinical settings. They require mixing on-site and are classified as Class II medical devices under FDA regulations, with a 510(k) clearance for dental applications. Sterility and handling instructions are manufacturer-specific, and sizes vary by formulation (e.g., powder/liquid ratios). No MRI safety data is provided.
Frequently asked questions
What clinical applications are these glass ionomer cements primarily used for in dental procedures?
These cements are designed for bonding to metal bands, enamel, and dentin, making them ideal for orthodontic applications (such as securing brackets) and restorative procedures. Their self-curing, radiopaque properties provide durable adhesion and long-term stability, along with fluoride release for added protection.
Are these glass ionomer cements intended for reuse in a clinical setting, or are they single-use only?
The cements are explicitly supplied as powder-liquid kits for single-use in clinical settings. They require on-site mixing, which means each kit is meant to be used once and then discarded, ensuring sterility and preventing cross-contamination.
How are these cements stored, and are there any specific handling instructions to note?
Storage and handling instructions are manufacturer-specific, but as a powder-liquid system, they should be kept in a dry, sealed environment until use. Since they are single-use and self-curing, proper storage ensures stability before mixing. Always follow Pulpdent Corporation’s guidelines to maintain efficacy.
What regulatory pathway was followed for FDA clearance of these glass ionomer cements?
The cements received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device for dental applications. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device, with a clearance date of May 31, 1995.
Are there multiple sizes or formulations available, and how do they differ?
The cements come in various formulations differentiated by powder-to-liquid ratios, as indicated by the multiple registration numbers. Each formulation may vary slightly in consistency or setting time, but all are designed for bonding applications. The exact differences depend on the specific kit purchased, so verifying the intended use (e.g., orthodontic vs. restorative) is recommended.
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, Ortho-Choice (Pulpdent) | Dental Product | Pearson Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951270 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K951270 24 fields · synced Sep 18, 2026