Identifiers
- 510(k) Number
- K180803 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BeautiBond Universal is a single-component adhesive classified as an Agent, Tooth Bonding, Resin. It is designed to bond dental restorative materials to enamel, dentin, composites, zirconia, alumina ceramics, and both precious and nonprecious alloys in a one-step process. The formulation eliminates the need for separate etching, priming, and bonding steps, streamlining clinical workflow while ensuring durable adhesion.
This adhesive is supplied as a single-component system, requiring no mixing, and is intended for use in dental settings. It is presented in a HEMA-free formulation to facilitate water removal and form a thin adhesive film (approximately 5 µm), making it particularly suitable for anterior restorations. The device is classified under FDA regulation 872.3200 and holds a 510(k) clearance (K180803) as substantially equivalent to a predicate device. No specific sterility or single-use/reusable designation is provided in the data.
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: BeautiBond® - Shofu USA, BeautiBond Universal - Shofu Dental, BeautiBond - Shofu Dental, BeautiBond® Xtreme - Shofu USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180803 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corporation
Sources (1)
- FDA 510(k) K180803 24 fields · synced Oct 1, 2026