Sinfony

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992645 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hytac

  Class II

  FDA 510(k) K992909 Active Cleared 24 Nov 1999

• Impregum Penta M Monosoft

  Class II

  FDA 510(k) K994192 Active Cleared 28 Jan 2000

• Pentamix 2

  Class I

  FDA 510(k) K991913 Active Cleared 26 Jul 1999

• Vitron M

  Class II

  FDA 510(k) K990763 Active Cleared 25 May 1999

• Vestogum

  Class II

  FDA 510(k) K991221 Active Cleared 20 May 1999

• Ketac Cem U

  Class II

  FDA 510(k) K002793 Active Cleared 26 Sep 2000

See all devices from Espe Dental AG →

• What is the primary clinical application for Sinfony?

  Sinfony is a light-cured composite resin designed for restorative dentistry. It is specifically indicated for the veneering of fixed and removable prostheses on metal frameworks, as well as the fabrication of inlays, onlays, individual crowns, fiber-reinforced bridges, and the customization of prefabricated teeth.

• What is the composition of the Sinfony material?

  Sinfony is formulated as an ultra-fine particle composite resin material composed of methacrylates. This composition allows it to function effectively as a veneering material for various dental prosthetic applications.

• What is the regulatory status of this device?

  Sinfony has received FDA 510(k) clearance under the traditional pathway, identified by K-number K992645. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.