Embrace Dual Cure Composite Materials
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071278 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Embrace Dual Cure Composite Materials are resin-based, hydrophilic dental composites designed for permanent cementation of dental restorations. These materials are intended for bonding to dentition, including the fixation of dental posts, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints, as well as intra-oral repair of porcelain crowns and as a build-up or repair material. They are formulated to release fluoride and are free of Bisphenol A.
These materials are supplied as a dual-cure system, requiring both light and chemical activation for optimal curing. They are intended for single-use applications in clinical dental settings and are classified under FDA 510(k) clearance (K071278) as substantially equivalent to a predicate device. The product is regulated under the Dental advisory committee category and is not intended for MRI use. Storage conditions and reusability are not specified in the available data.
Frequently asked questions
What types of dental restorations can the Embrace Dual Cure Composite Materials be used to permanently cement, and how does this differ from other repair uses?
The Embrace Dual Cure Composite Materials are specifically designed for permanent cementation of dental restorations such as dental posts, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints. Beyond cementation, they can also be used intra-orally for repairing porcelain crowns or as a build-up/repair material, offering versatility in both structural bonding and restoration repair scenarios.
How is the Embrace Dual Cure Composite Materials system activated, and why is this important for its use?
The Embrace Dual Cure Composite Materials require both light activation (via a curing lamp) and chemical activation to achieve optimal curing. This dual-cure mechanism ensures thorough polymerization, even in areas where light may not fully penetrate, such as deep or shaded regions of the mouth, improving durability and longevity of the bonded restoration.
Are the Embrace Dual Cure Composite Materials intended for reuse in clinical settings, and if not, what does this mean for inventory management?
The Embrace Dual Cure Composite Materials are explicitly intended for single-use applications in clinical settings. This means each application requires a new tube or capsule, which impacts inventory management by necessitating regular restocking and reducing the risk of cross-contamination or degradation from repeated handling.
What safety features or benefits does the Embrace Dual Cure Composite Materials offer compared to other dental composites?
The Embrace Dual Cure Composite Materials are formulated to release fluoride, which helps strengthen tooth enamel and reduce the risk of decay near the restoration site. Additionally, they are free of Bisphenol A (BPA), addressing concerns about chemical exposure in dental materials, making them a safer choice for patients.
How should clinicians determine the appropriate size or shade of Embrace Dual Cure Composite Materials for a specific patient’s restoration?
While the provided data does not specify exact sizes or shades, the Embrace Dual Cure Composite Materials are designed to match common dental restoration needs. Clinicians should refer to Pulpdent Corporation’s product documentation or shade guides (typically included in the packaging) to select the appropriate shade for aesthetic integration with the patient’s natural teeth. For sizing, the material is versatile enough to accommodate most standard restorative applications, but precise amounts depend on the specific restoration being cemented or repaired.
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: PDF Summary of Safety and Effectiveness N 2 9 Z007, K071278 FDA 510(k) - EMBRACE DUAL CURE COMPOSITE MATERIALS, EMBRACE DUAL CURE COMPOSITE MATERIALS - Innolitics, K071278 FDA 510(k) - EMBRACE DUAL CURE COMPOSITE MATERIALS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071278 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K071278 24 fields · synced Sep 18, 2026