Cercon Ceram

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K011333 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Deguplus 2

  Class II

  FDA 510(k) K833445 Active Cleared 26 Dec 1983

• Biosil F

  Class II

  FDA 510(k) K861820 Active Cleared 13 Jun 1986

• Albabond E

  Class II

  FDA 510(k) K883511 Active Cleared 6 Oct 1988

• Duallor R Solder

  Class II

  FDA 510(k) K844867 Active Cleared 25 Mar 1985

• Biosil H

  Class II

  FDA 510(k) K861787 Active Cleared 21 May 1986

• Albabond 60

  Class II

  FDA 510(k) K883758 Active Cleared 12 Oct 1988

See all devices from Degussa Dental, Inc. →

• What is the intended use of Cercon Ceram?

  Cercon Ceram is a porcelain powder specifically formulated for use in prosthetic dentistry. It is intended for the production of artificial teeth for fixed or removable dentures, as well as for creating jacket crowns, facings, and veneers.

• How is the Cercon Ceram powder processed into a dental prosthesis?

  To create a hard prosthesis, the Cercon Ceram powder mixture must be heated to a high temperature within a dental oven. This thermal process transforms the powder into the final, durable form required for dental applications.

• What are the primary components of this porcelain powder?

  Cercon Ceram is composed of a mixture of substances including kaolin, felspar, and quartz. These materials are combined to provide the necessary properties for the fabrication of dental restorations.

• Is there regulatory information available for this device?

  Yes, Cercon Ceram is identified under FDA 510(k) clearance number K011333. This indicates that the device was reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.