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Poly-Tone Denture Base Resin

by General Dental Products, Inc.

510(k) K823568

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823568 Date12 Jan 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Poly-Tone Denture Base Resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, repair a fractured denture, or form a new denture base. It is designed to provide optimal fit, comfort, and esthetics for removable prostheses. The resin is available in various processing methods including heat cure, microwave cure, and pour.

This device is not available for over-the-counter use and is supplied as a single-use product. It is stored according to manufacturer instructions and has been cleared by the FDA under 510(k) number K823568 for dental applications. The device is MRI safe and comes in various shades and handling characteristics depending on the processing method selected.

Other devices from General Dental Products, Inc.

Questions

AI-generated answers, 28 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 Poly-Tone Denture Base Resin used for?

    Poly-Tone Denture Base Resin is used to reline denture surfaces that contact tissue, repair fractured dentures, or form new denture bases. It provides optimal fit, comfort, and esthetics for removable prostheses.

  • How is Poly-Tone Denture Base Resin supplied and what are its processing methods?

    Poly-Tone Denture Base Resin is supplied as a single-use product and is not available for over-the-counter use. It is available in various processing methods including heat cure, microwave cure, and pour, with different shades and handling characteristics depending on the selected method.

  • Is Poly-Tone Denture Base Resin MRI safe and what is its regulatory status?

    Yes, Poly-Tone Denture Base Resin is MRI safe. It has been cleared by the FDA under 510(k) number K823568 for dental applications. The device is not available for over-the-counter use and should be stored according to manufacturer instructions.