Clearfil SE Bond Plus
by Kuraray Medical, Inc. 510(k)
Active
510(k) K023842
Overview
Clearfil SE Bond Plus is a two-step self-etch adhesive system designed for bonding dental restorations to tooth structure. Classified as an Agent, Tooth Bonding, Resin, it facilitates durable adhesion between composite resins and enamel/dentin, improving the longevity and integrity of restorative treatments. The formulation incorporates advanced bonding technology to enhance mechanical retention and reduce post-operative sensitivity, supporting clinical outcomes in restorative dentistry.
This adhesive is supplied as a single-use, non-sterile kit intended for use in dental offices. It requires manual application and light-curing, with no regulatory restrictions on MRI compatibility. The system is classified under FDA Device Class II (KLE) and holds a 510K clearance (K023842) for dental applications. Storage should follow manufacturer guidelines to maintain efficacy, though specific sterility or reuse instructions are not indicated in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023842 | Date11 Feb 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kuraray Medical, Inc.
Questions
What is Clearfil SE Bond Plus used for in dental procedures?
Clearfil SE Bond Plus is a two-step self-etch adhesive system designed specifically for bonding dental restorations to tooth structure. It enhances the adhesion between composite resins and both enamel and dentin, which helps improve the durability and integrity of restorative treatments. This is particularly useful in procedures where strong, long-lasting bonds are critical, such as fillings or crowns.
How is Clearfil SE Bond Plus supplied and what are its handling requirements?
Clearfil SE Bond Plus is supplied as a single-use, non-sterile kit. It is intended for use in dental offices and requires manual application followed by light-curing. Since it is non-sterile, it should be handled in a clean environment to prevent contamination. The manufacturer’s storage guidelines should be followed to maintain the adhesive’s efficacy, though specific sterility or reuse instructions are not provided.
Is Clearfil SE Bond Plus intended for single-use or can it be reused?
Clearfil SE Bond Plus is explicitly supplied as a single-use kit. Reusing adhesive systems can compromise sterility and performance, potentially leading to clinical complications. Always adhere to the manufacturer’s instructions to ensure optimal results and patient safety.
What are the key benefits of using Clearfil SE Bond Plus in restorative dentistry?
The primary benefits of Clearfil SE Bond Plus include its advanced bonding technology, which provides durable mechanical retention between composite resins and tooth structure. This adhesive system is formulated to reduce post-operative sensitivity, a common issue in dental restorations, and supports improved clinical outcomes. Its self-etch properties simplify application while maintaining strong adhesion.
How should Clearfil SE Bond Plus be stored to ensure its effectiveness?
While the regulatory data does not specify exact sterility or reuse instructions, Clearfil SE Bond Plus should be stored according to the manufacturer’s guidelines to preserve its efficacy. Proper storage typically involves keeping the adhesive in a cool, dry place, away from direct sunlight or extreme temperatures. Always check the packaging for detailed storage instructions to avoid degradation of the adhesive properties.