Myerson/Kenson GP Polymer

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

510(k) Number

K813328 ↗

FDA Product Code

EBD

Device Class

Class II

Regulation

21 CFR Part 872.3310

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Naso-Gard Nasogastric Tube Holder

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• Extended Balljoint Grip

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See all devices from Howmedica Corp. →

• What is the Myerson/Kenson GP Polymer used for in dental applications?

  The Myerson/Kenson GP Polymer is a Class II dental device classified as a coating, filling material, and resin. It is specifically designed for use in restorative dental procedures to help restore the function and appearance of teeth.

• How is the Myerson/Kenson GP Polymer supplied and what is its regulatory status?

  The device is supplied by Howmedica Corp. and received FDA 510(k) clearance on February 24, 1982. It is regulated under product code EBD with special controls, indicating it meets specific safety and effectiveness requirements for dental applications.

• Is the Myerson/Kenson GP Polymer sterile and can it be reused?

  The device data does not provide information regarding sterility or single-use status. Clinicians should consult the manufacturer's instructions for use to determine proper handling, sterilization procedures if applicable, and whether the device is designed for single or multiple use.

• What sizes and models of the Myerson/Kenson GP Polymer are available?

  The device data does not specify available sizes or models for the Myerson/Kenson GP Polymer. Dental professionals should contact Howmedica Corp. directly or refer to the product documentation for detailed information about available configurations and specifications.