Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K014138 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 Triple-Cure Reinforced Glass Ionomer Orthodontic Cement is a dental adhesive classified as an Adhesive, Bracket And Tooth Conditioner, Resin under FDA nomenclature. It is a reinforced glass ionomer material designed to bond orthodontic brackets and bands to teeth, combining the chemical stability of glass ionomer with the mechanical strength of dental resin technology. Its fluoride-releasing properties contribute to remineralization and caries prevention, while its dual-cure mechanism ensures reliable adhesion through both self-cure and light-cure activation.
This cement is supplied as a powder-liquid system for professional use in clinical settings, requiring mixing and application by a dental practitioner. It is intended for single-use per manufacturer specifications and is not intended for reuse. The product adheres to FDA regulatory standards under 510K clearance (K014138) and falls under Device Class II (872.3750). No MRI safety information or sterility claims are provided in the specifications.
Frequently asked questions
What is the primary purpose of the Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement in clinical practice?
This cement is specifically designed to bond orthodontic brackets and bands securely to teeth. It combines glass ionomer chemistry for chemical stability with resin technology for mechanical strength, ensuring durable adhesion. The fluoride-releasing properties also help promote remineralization and prevent tooth decay, making it ideal for orthodontic treatments where long-term stability and caries protection are critical.
How is the Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement supplied, and what does the mixing process involve?
The cement is supplied as a powder-liquid system, meaning it requires manual mixing by a dental practitioner before use. The powder and liquid components must be combined according to the manufacturer’s instructions to achieve the proper consistency for application. This ensures optimal bonding performance and adherence to the dual-cure mechanism (self-cure + light-cure activation).
Is this cement intended for single-use only, and what are the implications for clinical workflow?
Yes, the manufacturer specifies that this cement is intended for single-use only. This means each mixed batch should be used for one patient and discarded afterward, reducing the risk of cross-contamination and ensuring consistent performance. Clinicians must prepare a fresh mixture for each application to maintain reliability and sterility.
Does the Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement have any special storage requirements, and how should it be handled?
While the provided data does not explicitly detail storage conditions, reinforced glass ionomer cements like this typically require protection from moisture, extreme temperatures, and direct light. The powder-liquid system should be stored in a cool, dry place (as per standard dental adhesive protocols) until use. Always follow the manufacturer’s instructions for optimal shelf life and performance.
What regulatory pathway was followed for FDA clearance of this product, and what class does it fall under?
The Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement received FDA clearance through a 510(k) submission (K014138), classified under the Traditional 510(k) pathway with a Substantially Equivalent (SESE) determination. It is categorized as Device Class II (872.3750), meaning it undergoes additional regulatory scrutiny to ensure safety and effectiveness for bonding orthodontic appliances to teeth.
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 Triple-cure Reinforced Glass Ionomer Orthodontic Cement ..., PDF Pulpdent Triple-CureTM Reinforced Glass Ionomer Orthodontic Cement, Pulpdent Triple-cure Reinforced Glass Ionomer Orthodontic Cement ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K014138 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K014138 24 fields · synced Oct 6, 2026