Degufill Etchant

No FDA recalls on record, checked 22 Oct 2026.

Full name

Degufill (R) Etchant

510(k) Number

K901872 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

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 Etchant used for?

  Degufill Etchant is a dental etchant device specifically designed for tooth preparation procedures in dental applications. It is classified as a Material, Tooth Shade, Resin product and is intended to be used by dental professionals during various dental treatments.

• Is Degufill Etchant single-use or reusable?

  The device information does not specify whether Degufill Etchant is designed for single-use or reusable purposes. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols for this dental etchant product.

• What regulatory approvals does Degufill Etchant have?

  Degufill Etchant received FDA 510(k) clearance on August 1, 1990, with the product code EBF. It is classified as a Class II device under special controls and was reviewed by the Dental advisory committee. The device was determined to be substantially equivalent to other legally marketed devices.

• What information is available about the sterility and storage of Degufill Etchant?

  The provided device information does not include specific details regarding the sterility status or recommended storage conditions for Degufill Etchant. Dental professionals should consult the manufacturer's documentation for proper handling, storage, and any sterility requirements for this dental etchant product.