Embrace WetBond Clear Sealant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052281 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 Clear Sealant is a dental sealant, pit and fissure conditioner, and resin-based material designed to seal dental surfaces and prevent microleakage. It is a light-cured, hydrophilic material intended for application to pits, fissures, and small surface defects, including buccal pits and lingual grooves, as well as orthodontic bracket coatings. The sealant hardens to a clear finish upon curing, providing a smooth and durable protective layer.
This device is supplied as a single-use, non-sterile material intended for use in clinical dental settings. It is classified as a Class II medical device under FDA regulations (21 CFR 872.3765) and holds a 510(k) clearance (K052281) for substantial equivalence in dental applications. The material is packaged for dental professional use and requires light activation for curing. No additional regulatory markings or sterility claims are specified.
Frequently asked questions
What clinical applications is the Embrace WetBond Clear Sealant intended for?
The Embrace WetBond Clear Sealant is designed to seal dental surfaces, particularly pits and fissures, and can also be used as a conditioner. It is specifically intended for application to small surface defects like buccal pits, lingual grooves, and as a coating for orthodontic brackets. Its hydrophilic, light-cured formula creates a smooth, durable protective layer to help prevent microleakage.
Is the Embrace WetBond Clear Sealant sterile, and how is it supplied?
The Embrace WetBond Clear Sealant is not sterile and is supplied as a single-use material for clinical dental settings. It comes packaged for professional use, requiring no additional sterilization before application.
How is the Embrace WetBond Clear Sealant activated and cured?
The Embrace WetBond Clear Sealant is a light-cured material, meaning it requires activation by a dental curing light to harden into a clear, protective seal. This ensures proper bonding and durability on treated surfaces.
What regulatory pathway was followed for FDA clearance of this device?
The Embrace WetBond Clear Sealant received FDA 510(k) clearance (K052281) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II dental device under 21 CFR 872.3765 and is intended for dental applications as determined by the Dental Advisory Committee (DE).
Can this sealant be reused, or is it strictly single-use?
The Embrace WetBond Clear Sealant is explicitly labeled as single-use only, meaning each package is intended for one application in a clinical setting. Reuse is not recommended or supported by the manufacturer.
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™ Seal-n-Shine™ - PULPDENT, EMBRACE WETBOND CLEAR SEALANT (K052281) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052281 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K052281 24 fields · synced Sep 18, 2026