Degubond Lite

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K912493 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Part 872 Degufill H & Degufill M Da

  Class I

  FDA 510(k) K914368 Active Cleared 13 Nov 1991

• Futura One

  Class II

  FDA 510(k) K950187 Active Cleared 24 Mar 1995

• Dentomat 3 Amalgamators

  Class I

  FDA 510(k) K914339 Active Cleared 7 Nov 1991

• Degufill (Tm) Bond

  Class II

  FDA 510(k) K902744 Active Cleared 15 Aug 1990

• Degussa Stopfgold (Degussa Direct-Filling Gold)

  Class II

  FDA 510(k) K902387 Active Cleared 28 Jun 1990

• Palliag Nf IV

  Class II

  FDA 510(k) K951789 Active Cleared 14 Jun 1995

See all devices from Degussa AG →

• What is the Degubond Lite used for in dental procedures?

  The Degubond Lite is specifically designed for bonding noble metal alloys to tooth structures in restorative dentistry. It ensures a durable attachment of dental restorations, such as crowns or bridges, to prepared teeth, providing long-lasting stability for the patient.

• Is the Degubond Lite a single-use or reusable device?

  The Degubond Lite is supplied as a reusable dental adhesive system. This means it is intended for repeated use in clinical settings, provided it is properly cleaned, maintained, and stored according to manufacturer guidelines.

• What regulatory approval does the Degubond Lite hold?

  The Degubond Lite has received FDA 510(k) clearance under the reference number K912493. It is classified as a Class II device with product code EJS, indicating it meets regulatory standards for dental adhesive systems in the United States.

• Does the Degubond Lite come with any specific storage instructions?

  The provided specifications do not explicitly detail storage instructions for the Degubond Lite. However, as a reusable device, it should be stored in a clean, dry environment, protected from contamination and moisture, to maintain its effectiveness and sterility between uses.

• What types of dental restorations can the Degubond Lite be used with?

  The Degubond Lite is intended for bonding noble metal alloys to tooth structures, making it suitable for securing restorations such as crowns, bridges, or other fixed prosthetics that require durable attachment to prepared teeth.