Impregum Garant L Duosoft

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K994190 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hytac

  Class II

  FDA 510(k) K992909 Active Cleared 24 Nov 1999

• Impregum Penta M Monosoft

  Class II

  FDA 510(k) K994192 Active Cleared 28 Jan 2000

• Pentamix 2

  Class I

  FDA 510(k) K991913 Active Cleared 26 Jul 1999

• Vitron M

  Class II

  FDA 510(k) K990763 Active Cleared 25 May 1999

• Vestogum

  Class II

  FDA 510(k) K991221 Active Cleared 20 May 1999

• Ketac Cem U

  Class II

  FDA 510(k) K002793 Active Cleared 26 Sep 2000

See all devices from Espe Dental AG →

• Is Impregum Garant L Duosoft intended for use in specific dental procedures, or is it a general impression material for all dental restorations?

  Impregum Garant L Duosoft is a low-viscosity polyether-based dental impression material designed specifically for capturing dental structures to create accurate impressions. It is intended for use in clinical dental settings by professionals to aid in the fabrication of prosthetics, but it is not limited to a single procedure. Instead, it is a versatile material compatible with standard dental laboratory workflows for creating precise molds of oral anatomy, which can then be used for various restorative treatments.

• How is Impregum Garant L Duosoft supplied, and what should I know about its sterility and reusability?

  Impregum Garant L Duosoft is supplied as a reusable component of the Garant dispenser system. It is not sterile at the time of supply, meaning it must be sterilized or prepared appropriately before clinical use. Additionally, it is intended for single-use per application, meaning each impression should be discarded after use to ensure accuracy and hygiene.

• What regulatory pathway was followed for FDA clearance of Impregum Garant L Duosoft, and what does that mean for its use in the U.S.?

  Impregum Garant L Duosoft received FDA clearance through a 510(k) submission, classified as substantially equivalent under regulation number 872.3660 and reviewed by the Dental Advisory Committee. This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use as a dental impression material.

• Does Impregum Garant L Duosoft come in multiple sizes or models, and how does that affect its clinical application?

  The provided data does not specify distinct sizes or models of Impregum Garant L Duosoft beyond its classification as a low-viscosity polyether-based impression material. However, since it is part of the Garant dispenser system, it is likely designed to be compatible with various dental tray sizes and impression techniques. Clinicians should refer to the manufacturer’s instructions for specific tray recommendations and application guidance.