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Clearfil CR Inlay

by Kuraray Co. 510(k)

Active United States

510(k) K890123

Overview

The Clearfil CR Inlay is a dental restoration material classified as a Composite Inlay (Product Code: EBF), designed for indirect dental fillings. It is a radiopaque, light-cured composite resin intended to restore posterior teeth by filling cavities with a durable, tooth-colored material that mimics natural dentition.

This device is supplied as a reusable kit containing composite resin components for dental technicians to fabricate inlays in a laboratory setting. Sterilization instructions are not applicable as it is not a single-use item; however, it must be handled under aseptic conditions in a controlled dental environment. The product received FDA 510(k) clearance under the Traditional pathway in 1989 (K890123) and is intended for use in dental offices by trained professionals.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890123 Date31 Mar 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Clearfil CR Inlay used for in clinical practice?

    The Clearfil CR Inlay is designed for indirect dental restorations, specifically to fill cavities in posterior teeth (molars and premolars). It is a composite resin material that is cured with light to create a durable, tooth-colored filling that closely resembles natural dentition, improving both function and aesthetics.

  • How is the Clearfil CR Inlay supplied, and is it intended for single-use?

    The Clearfil CR Inlay is supplied as a reusable kit containing composite resin components meant for dental technicians to fabricate inlays in a laboratory environment. It is not a single-use item, so sterilization instructions do not apply. However, it must be handled under aseptic conditions to maintain a controlled, sterile environment during use.

  • Can this device be reused, and if so, what precautions should be taken?

    Yes, the Clearfil CR Inlay kit is reusable, as it is intended for laboratory fabrication of multiple inlays. Since it is not a single-use item, sterilization is not required, but it must be handled in a clean, controlled environment to prevent contamination. Dental professionals should follow standard aseptic techniques to ensure the components remain suitable for use.

  • What regulatory pathway was followed for FDA clearance of the Clearfil CR Inlay?

    The Clearfil CR Inlay received FDA 510(k) clearance under the Traditional pathway in 1989, with the submission reviewed by the Dental Devices (DE) Advisory Committee. The device was determined to be substantially equivalent to a legally marketed predicate, as indicated by the decision code SESE (Substantially Equivalent to a Special Control Device).