Degufill Bond

No FDA recalls on record, checked 22 Oct 2026.

Full name

Degufill (R) Bond

510(k) Number

K901870 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

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 DEGUFILL Bond used for in dental procedures?

  DEGUFILL Bond is a dental resin bonding agent specifically designed to bond resin materials to teeth. It is intended for use in tooth bonding procedures as a Class II medical device with product code KLE.

• How is DEGUFILL Bond supplied and what is its regulatory status?

  DEGUFILL Bond is supplied by Degussa AG and received FDA 510(k) clearance on August 6, 1990, with the decision code SESE (Substantially Equivalent). It is regulated under number 872.3200 and was reviewed by the Dental advisory committee.

• Is DEGUFILL Bond a single-use device or can it be reused?

  The device data does not specify whether DEGUFILL Bond is single-use or reusable. For proper usage instructions and information about reusability, please consult the product documentation or contact the manufacturer directly.

• What sizes and models of DEGUFILL Bond are available?

  The device data does not provide information about specific sizes or models of DEGUFILL Bond. For detailed information about available variants, please refer to the manufacturer's product catalog or contact Degussa AG directly.