Coltene President Impression Materials

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

510(k) Number

K811767 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Coltene Pressure Spot Indicator

  Class II

  FDA 510(k) K811667 Active Cleared 15 Jul 1981

• Coltene President Jet Regular Body

  Class II

  FDA 510(k) K882800 Active Cleared 23 Sep 1988

• Cool Temp Natural

  Class II

  FDA 510(k) K041098 Active Cleared 13 May 2004

• Coltene Jet-Mixer

  Class I

  FDA 510(k) K863998 Active Cleared 30 Oct 1986

• Coltene Coltex/Coltoflax

  Class II

  FDA 510(k) K811666 Active Cleared 15 Jul 1981

• Coltene President Jet Impression Materials System

  Class I

  FDA 510(k) K873671 Active Cleared 27 Oct 1987

See all devices from Coltene, Inc. →

• What types of dental procedures are the Coltene President Impression Materials designed to support?

  The Coltene President Impression Materials are addition-curing silicone impression materials specifically designed to create highly accurate and detailed replicas of oral structures. These replicas are used for diagnostic purposes, treatment planning, and the fabrication of dental prostheses, such as crowns, bridges, dentures, and other restorative devices.

• Are the Coltene President Impression Materials intended for single-use or can they be reused?

  The Coltene President Impression Materials are explicitly intended for single-use in dental offices. They are not designed or approved for reuse, which helps maintain precision and sterility for each patient.

• How are the Coltene President Impression Materials packaged and stored before use?

  The materials are not sterile at shipment but are packaged to maintain sterility until the time of use. This means they should be stored according to the manufacturer’s instructions to preserve their integrity, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway was followed for the Coltene President Impression Materials, and what class does this device fall under?

  The Coltene President Impression Materials were granted 510(k) clearance through the traditional review pathway by the FDA in 1981. They are classified as Class II devices under FDA regulation 872.3660, which is the regulatory category for dental impression materials.

• How do I identify the specific variant of Coltene President Impression Material I’m using?

  Each variant of the Coltene President Impression Materials is assigned a unique FEI number (e.g., 4565, 3003762341, etc.), which ensures traceability and compliance. These numbers are listed on the packaging or documentation, allowing you to distinguish between different consistencies or formulations.