Embrace Wet-Bond Restorative Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031877 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 Wet-Bond Restorative Material is a dental restorative composite designed for bonding to moist tooth surfaces. Classified under dental restorative materials, it is formulated to provide durable adhesion and fluoride release, supporting long-term restoration integrity.
This material is supplied as a dual-cure, fluoride-releasing resin cement, intended for use in restorative and cosmetic dental procedures. It is packaged as a syringe refill (7g/ea) and is intended for single-use applications in clinical settings. Authorized under FDA 510(k) clearance (K031877), it adheres to dental regulatory standards for restorative materials.
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: Embrace™ WetBond™ - PULPDENT, Embrace™ WetBond™ Pit & Fissure Sealant - PULPDENT, Embrace WetBond EMCMR Resin Cement - Henry Schein Dental, Embrace™ WetBond™ Ciment - PULPDENT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031877 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K031877 24 fields · synced Sep 18, 2026