Tulux-Filter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K892517 ↗

FDA Product Code

EBZ

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Palgaflex and Palgaflex-Quick

  Class II

  FDA 510(k) K884381 Active Cleared 4 Jan 1989

• Permagum Adhesive

  Class II

  FDA 510(k) K771853 Active Cleared 13 Oct 1977

• Photac-Bond

  Class II

  FDA 510(k) K904096 Active Cleared 19 Nov 1990

• Rocatec(R) -Plus

  Class II

  FDA 510(k) K913857 Active Cleared 16 Dec 1991

• Visio-Perl

  Class II

  FDA 510(k) K882566 Active Cleared 19 Oct 1988

• Espe Ketac-Cem Radiopaque

  Class II

  FDA 510(k) K844846 Active Cleared 25 Mar 1985

See all devices from Espe GmbH (Us) →