REPLICA

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

510(k) Number

K925746 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hi Bond Non-Precious Ceramic Alloy

  Class II

  FDA 510(k) K992881 Active Cleared 19 Nov 1999

• Kromatica Color Changing Alginate

  Class II

  FDA 510(k) K974894 Active Cleared 12 Feb 1998

• Durabond Non-Precious Ceramic Alloy

  Class II

  FDA 510(k) K010069 Active Cleared 15 Feb 2001

• Ceradium V Non-Precious Ceramic Alloy

  Class II

  FDA 510(k) K993572 Active Cleared 13 Dec 1999

• Ceradium Non-Precious Ceramic Alloy

  Class II

  FDA 510(k) K992705 Active Cleared 22 Sep 1999

• What is the REPLICA dental material used for?

  REPLICA is a dental material specifically designed for creating impressions to capture detailed anatomical structures for dental applications. It helps dentists obtain accurate molds of teeth and oral tissues for various dental procedures.

• How is the REPLICA device supplied and what is its regulatory status?

  The REPLICA device is supplied by Matech, Inc. and has received FDA 510K clearance with product code ELW. It is regulated under number 872.3660 and is classified as a Class II device for dental specialty use.

• Is the REPLICA device single-use or reusable?

  The device data does not specify whether REPLICA is single-use or reusable. For proper usage instructions and disposal information, users should consult the product documentation provided by Matech, Inc. or contact the manufacturer directly.

• What are the storage requirements for the REPLICA dental material?

  The device data does not include specific storage requirements for the REPLICA dental material. Users should follow the manufacturer's guidelines for storage conditions, which are typically included in the product packaging or documentation to maintain the material's integrity and performance.