Embrace WetBond Pit and Fissure Sealant, Low Fill
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113818 FDA 510(k)
- FDA Product Code
- EBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3765 FDA 510(k)
- Regulation Number
- 872.3765 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Embrace WetBond Pit and Fissure Sealant, Low Fill is a dental sealant designed to protect the occlusal surfaces of teeth by preventing bacterial penetration into pits and fissures. Classified as a pit and fissure sealant, it adheres to moist tooth surfaces, providing a durable barrier against caries development.
This single-use, non-sterile device is supplied in a kit and is intended for use in dental offices. It requires no additional bonding agents and is compatible with standard dental procedures. The product has received FDA 510(k) clearance under the Traditional pathway and is categorized under device class II (872.3765). No MRI safety information is specified.
Frequently asked questions
What is the Embrace WetBond Pit and Fissure Sealant, Low Fill primarily used for in dental procedures?
The Embrace WetBond Pit and Fissure Sealant, Low Fill is designed to protect the occlusal (chewing) surfaces of teeth by creating a durable barrier against bacterial penetration in pits and fissures. This helps prevent the development of cavities, particularly in areas where plaque and food debris can easily accumulate.
Is this sealant compatible with standard dental procedures, and does it require any additional bonding agents?
Yes, the Embrace WetBond Pit and Fissure Sealant is compatible with standard dental procedures and does not require any additional bonding agents. It is specifically formulated to adhere effectively to moist tooth surfaces, simplifying application in clinical settings.
How is the Embrace WetBond Pit and Fissure Sealant supplied, and is it single-use or reusable?
The Embrace WetBond Pit and Fissure Sealant is supplied as a single-use device in a kit, which is intended for use in dental offices. This design ensures sterility and safety for each patient application, as it is not intended for reuse.
What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?
The Embrace WetBond Pit and Fissure Sealant received FDA clearance through the Traditional 510(k) pathway, specifically under the Dental advisory committee (DE). It is classified as a Class II device under the product code 872.3765, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
Does the Embrace WetBond Pit and Fissure Sealant have any specific storage requirements, and is it sterile?
The device is non-sterile and supplied in a kit for single-use in dental offices. While specific storage instructions are not detailed in the provided data, typical dental sealants like this are generally stored in a cool, dry place away from direct sunlight to maintain product integrity until use.
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™ Pit & Fissure Sealant - PULPDENT, Embrace™ WetBond™ - PULPDENT, Embrace Wetbond EMSWB Low Fill Pit & Fissure Sealant, Embrace WetBond Pit and Fissure Sealant, Low Fill Kit, Off-White Shade, Embrace WetBond Pit & Fissure Sealant Low Fill Off White Kit 4Bx
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113818 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K113818 24 fields · synced Sep 20, 2026