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CS-11 Denture Hydrophilic Resin Coating

by Chema-Scutum, Inc.

510(k) K832500

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832500 Date27 Oct 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Cs-11
510(k) Number
FDA Product Code
EBE
Device Class
Class II
Regulation
21 CFR Part 872.3300
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CS-11 is a Denture Hydrophilic Resin Coating, classified under FDA product code EBE. This device is designed to provide a protective hydrophilic resin layer for dentures, enhancing their durability and moisture retention to improve patient comfort and longevity. The coating is intended to reduce porosity and improve adhesion of denture materials, ensuring better retention of denture adhesives and overall performance.

The CS-11 is supplied as a single-use coating system for dental laboratories and practitioners. It is intended for application in a controlled environment, adhering to standard dental laboratory procedures. The device is regulated under FDA 510(k) clearance (K832500) and falls under Class II medical devices, with no specific sterility requirements stated beyond typical dental laboratory hygiene protocols. Storage instructions are not detailed in the data, but it is supplied in a manner consistent with dental resin coatings, requiring proper ventilation and adherence to manufacturer guidelines.

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CS-11 Denture Hydrophilic Resin Coating used for in a dental setting?

    The CS-11 is designed to apply a protective hydrophilic resin layer to dentures, improving their durability and moisture retention. This enhances patient comfort and extends the denture’s lifespan by reducing porosity and strengthening the adhesion of denture materials, which helps denture adhesives perform better.

  • Is the CS-11 intended for single-use or repeated applications on dentures?

    The CS-11 is supplied as a single-use coating system, meaning each application is meant for one denture. It is intended for use in dental laboratories or by practitioners following standard procedures, ensuring proper application in a controlled environment.

  • How is the CS-11 regulated, and what class does it fall under?

    The CS-11 is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K832500). This means it has been determined to be substantially equivalent to a legally marketed device and is subject to general controls and special controls specific to dental coatings.

  • Are there any special storage requirements for the CS-11, or can it be stored like other dental resin coatings?

    While specific storage instructions aren’t detailed in the data, the CS-11 is supplied similarly to other dental resin coatings. It should be stored in a way that maintains its integrity, with proper ventilation and adherence to the manufacturer’s guidelines to ensure optimal performance.