Clearfil AP-X PLT
by Kuraray Medical, Inc. 510(k)
Active
510(k) K023002
Overview
Clearfil AP-X PLT is a light-cure universal composite resin indicated for dental restorations. Classified as a dental restorative material, it is designed for both posterior and anterior applications, providing durable and aesthetically pleasing results. Its radiopaque properties enhance visibility under X-ray imaging, while its high filler content ensures strength and longevity under occlusal forces. The material is formulated for use in direct composite restorations, offering high polishability and accurate color matching to natural tooth structures.
This composite is supplied as a light-cure restorative resin intended for single-use in dental procedures. It requires curing with a dental light source and is not intended for reuse. The device is regulated under FDA 510(k) clearance (K023002) as a dental restorative material, with no specific MRI safety or sterility requirements stated in the data. Storage conditions are not detailed, but standard dental practice guidelines for composite resins should be followed. The product is distributed under the product code EBF and is manufactured by Kuraray Medical, Inc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023002 | Date25 Oct 2002 | 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- Withdrawn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
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kuraray Medical, Inc.
Questions
What is the Clearfil AP-X PLT used for?
The Clearfil AP-X PLT is a light-cure universal composite resin designed specifically for dental restorations. It is suitable for both posterior (back teeth) and anterior (front teeth) applications, providing durable, aesthetically pleasing results that closely match natural tooth color. Its radiopaque properties also allow for clear visibility under X-ray imaging, which is useful for monitoring restoration placement and integrity over time.
How is the Clearfil AP-X PLT supplied and intended for use?
The Clearfil AP-X PLT is supplied as a single-use dental restorative resin. It requires activation with a dental light source to cure, meaning it must be polymerized immediately before use in a dental procedure. The material is not intended for reuse after opening or curing, adhering to standard single-use protocols for composite resins.
Is the Clearfil AP-X PLT sterile or reusable?
The Clearfil AP-X PLT is not described as sterile in the provided data, so it should be handled under standard dental aseptic conditions. It is explicitly intended for single-use only, meaning each application requires a new, uncured tube of the material. Reuse is not recommended or supported by the manufacturer.
What storage conditions should be followed for the Clearfil AP-X PLT?
While specific storage instructions are not detailed in the provided data, standard dental practice guidelines for composite resins should be followed. This typically includes storing the material in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use to maintain product integrity.
What regulatory pathway does the Clearfil AP-X PLT follow?
The Clearfil AP-X PLT is regulated under the FDA’s 510(k) clearance pathway, specifically classified as a dental restorative material. It was determined to be substantially equivalent to a predicate device and received clearance under the traditional review process. The product code assigned is EBF, and the clearance number is K023002.