Extrude Modified

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

510(k) Number

K012405 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Sealapex 4

  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →

• What clinical scenarios is the Extrude Modified impression material primarily used for?

  The Extrude Modified is designed for capturing precise dental impressions in clinical settings, enabling the creation of dental prosthetics, orthodontic appliances, or restorative work. Its accuracy and detail make it ideal for scenarios requiring exact replicas of oral structures, such as crowns, bridges, dentures, or orthodontic retainers.

• How is the Extrude Modified supplied, and what viscosity options are available?

  The Extrude Modified is supplied as a two-part base/catalyst system in three viscosities: Wash (for fine details), Medium (for general use), and Extra (for heavy-body applications). It comes packaged in either tubes or cartridges, allowing flexibility based on clinical preference and workflow.

• Is the Extrude Modified intended for single-use or reusable applications, and how should it be handled?

  The Extrude Modified is explicitly intended for single-use only to ensure patient safety. Since it must be handled under sterile conditions, it should be used in a controlled dental office environment, following standard aseptic protocols for impression materials.

• What regulatory pathway was followed for FDA clearance of the Extrude Modified?

  The Extrude Modified received FDA clearance through a 510(k) premarket submission (K012405) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) by the Dental (DE) Advisory Committee. This classification confirms its compliance with FDA standards for Class II dental impression materials.

• How should the Extrude Modified be stored, and are there any special handling instructions?

  Storage and handling of the Extrude Modified follow standard dental material protocols. Since it is a two-part system, it should be stored in a cool, dry place away from direct sunlight, as per typical guidelines for polyvinylsiloxane impression materials. Always check the manufacturer’s instructions for expiration dates and stability conditions.