Deguflex Monophase

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K901865 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

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 clinical purpose does Deguflex Monophase serve?

  Deguflex Monophase is formulated to capture detailed dental arch impressions during restorative and prosthetic procedures. Its composition allows clinicians to obtain accurate replicas of oral tissues, which are essential for fabricating crowns, bridges, and orthodontic appliances.

• How is Deguflex Monophase supplied and is it sterile?

  The product is supplied by Degussa AG in sealed packaging intended for single‑use in a clinical setting. The packaging is sterilized, ensuring the material remains free of microbial contamination until opened for use.

• Is Deguflex Monophase a single‑use or reusable product?

  Deguflex Monophase is a single‑use impression material. After an impression is taken, the material cannot be safely reprocessed, so a new package must be used for each patient to maintain hygiene and performance standards.

• What regulatory classification applies to Deguflex Monophase?

  The device is classified as Class II under product code ELW, subject to special controls. It received FDA 510(k) clearance (K901865) on September 6 1990, indicating it is substantially equivalent to a legally marketed predicate device.

• How should Deguflex Monophase be stored before use?

  The material should be stored in its original sealed container at room temperature, protected from moisture and extreme temperatures. Proper storage preserves its physical properties and ensures reliable impression quality when opened.