Permadyne Garant 2:1

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953374 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive

  Class II

  FDA 510(k) K960547 Active Cleared 15 Mar 1996

• Cojet System

  Class II

  FDA 510(k) K963735 Active Cleared 27 Nov 1996

• Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal, Sinfony Magic Modifiers, Sinfony Opaquer

  Class II

  FDA 510(k) K973513 Active Cleared 22 Dec 1997

• Microgliss

  Class II

  FDA 510(k) K954180 Active Cleared 21 Nov 1995

• Ebs (Espe Bonding System)

  Class II

  FDA 510(k) K962428 Active Cleared 12 Sep 1996

• Hytac Aplitip/Hytac Osb

  Class II

  FDA 510(k) K962442 Active Cleared 11 Sep 1996

See all devices from Espe GmbH & Co. Kg. →

• What is the primary use of the Permadyne Garant 2:1?

  This device is a dental impression material intended for use by professionals to capture the anatomical structures of a patient's oral cavity during dental procedures.

• Who is authorized to use this impression material?

  The Permadyne Garant 2:1 is supplied specifically for professional use within a dental setting, ensuring that it is handled by trained clinical staff.

• Has this device undergone regulatory review?

  Yes, the Permadyne Garant 2:1 has received FDA 510k clearance, which indicates that it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.