Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030036 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 Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement is a resin-reinforced glass ionomer dental cement (product code DYH) designed for dental applications. It combines fluoride-releasing properties with dual-cure polymerization, enabling reliable bonding and restoration in clinical settings.
This device is supplied as a two-paste system for use by dental professionals in orthodontic bracket/band bonding, metallic restoration cementation, and as a dental base/liner. It is classified under FDA regulation 872.3750 as a Class II device with Special Controls, and its FDA 510(k) clearance (K030036) confirms its substantial equivalence to a predicate device. No sterility or MRI safety information is specified.
Frequently asked questions
What clinical applications is this dental cement specifically designed for?
The Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement is designed for orthodontic bracket/band bonding, cementing metallic restorations, and use as a dental base or liner. Its dual-cure polymerization and fluoride-releasing properties support reliable bonding and restoration in these applications.
How is this product supplied, and is it intended for single-use or reuse?
This device is supplied as a two-paste system, meaning it comes in two separate pastes that must be mixed before use. The data does not specify sterility or reuse instructions, but its classification as a dental cement typically implies single-use per application in clinical settings.
What regulatory pathway was followed for FDA clearance, and what does that mean for its safety and effectiveness?
The Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement received FDA 510(k) clearance (K030036) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously cleared device of the same type, classified under FDA regulation 872.3750 as a Class II device with Special Controls.
Are there any special handling or storage requirements mentioned for this product?
The provided data does not specify any special handling or storage requirements such as temperature ranges, light sensitivity, or expiration details. However, as with most dental materials, it is generally recommended to follow manufacturer guidelines for optimal shelf life and performance.
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: K030036 FDA 510(k) - TRIPLE-CURE PASTE/PASTE RESIN-REINFORCE..., Triple-cure Paste/Paste Resin-reinforced Glass Ionomer Cement, TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030036 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K030036 24 fields · synced Sep 18, 2026