Identifiers
- 510(k) Number
- K896659 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)
The Silane Bond Enhancer is a dental agent classified as a Tooth Bonding Resin Agent, designed to improve adhesion between organic resins—such as composites and resin cements—and porcelain surfaces. It functions as a coupling agent, enhancing bond strength by chemically bridging the inorganic porcelain substrate with the organic resin matrix.
This single-component material is supplied in a syringe for precise dispensing, delivering one drop at a time. It is intended for use in dental settings after porcelain surfaces are etched and dried, requiring no additional mixing. The device is regulated under FDA 510(k) clearance (K896659) and falls under the classification of Class II medical devices (regulation number 872.3200). No sterility or MRI safety information is specified in the regulatory data.
Frequently asked questions
What is the Silane Bond Enhancer used for in dental procedures?
The Silane Bond Enhancer is specifically designed to improve adhesion between organic resins—such as composites and resin cements—and porcelain surfaces. It acts as a coupling agent, chemically bridging the inorganic porcelain with the organic resin matrix to enhance bond strength, which is critical for restorations like crowns or bridges.
How is the Silane Bond Enhancer supplied, and what does this mean for its use?
The Silane Bond Enhancer comes in a syringe format, allowing for precise dispensing of one drop at a time. This design ensures controlled application, which is essential for achieving accurate bonding in dental procedures without requiring additional mixing or dilution.
Is the Silane Bond Enhancer intended for single-use or can it be reused?
The Silane Bond Enhancer is not explicitly described as single-use or reusable in the provided data. However, since it is a dental agent supplied in a syringe for precise dispensing and is not labeled as sterile, it is typically intended for single-use per patient to maintain hygiene and prevent cross-contamination.
What regulatory pathway was followed for the FDA clearance of the Silane Bond Enhancer?
The Silane Bond Enhancer was cleared through the FDA’s 510(k) process, specifically under a *Traditional* clearance route. It was determined to be *Substantially Equivalent* to a predicate device and falls under the classification of Class II medical devices (regulation number 872.3200), indicating it poses moderate risk and requires special controls beyond general controls.
Does the Silane Bond Enhancer require any special preparation of the porcelain surface before application?
Yes, the Silane Bond Enhancer is intended for use *after* porcelain surfaces have been etched and dried. This preparation step ensures optimal adhesion by creating a clean, receptive surface for the coupling agent to chemically bond with the resin.
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: Silane Bond Enhancer - PULPDENT, : SILANE BOND ENHANCER - Pulpdent Corporation - PDF Catalogs ..., Silane Bond Enhancer - Pulpdent - Cargus International
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896659 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K896659 24 fields · synced Sep 18, 2026