Permagum Adhesive

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812117 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Etching Gel

  Class II

  FDA 510(k) K810266 Active Cleared 23 Feb 1981

• Nimetic Polishing Paste

  Class I

  FDA 510(k) K812118 Active Cleared 31 Aug 1981

• Visio-Band

  Class II

  FDA 510(k) K810265 Active Cleared 23 Feb 1981

• Permagum

  Class II

  FDA 510(k) K812116 Active Cleared 31 Aug 1981

• Visio-Seal

  Class II

  FDA 510(k) K811624 Active Cleared 26 Jun 1981

• Nimetic-Dispers

  Class II

  FDA 510(k) K812119 Active Cleared 31 Aug 1981

See all devices from Espe-Premier Sales Co. →

• What is Permagum Adhesive used for?

  Permagum Adhesive is a dental bonding agent classified as a resin agent. It is intended for use in dental applications to adhere materials to teeth.

• Is Permagum Adhesive a single-use device?

  Yes, the device is supplied as a single-use product and is not reusable.

• Is Permagum Adhesive sterile?

  The device is not specified as sterile in the provided data.

• What is the regulatory status of Permagum Adhesive?

  Permagum Adhesive is regulated under FDA 510(k) clearance with a decision code of SESE, indicating it is substantially equivalent to a predicate device.