Zentih Flowable Composite (Multiple)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970683 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Foremost Lite Cure Pit & Fissure Sealant

  Class II

  FDA 510(k) K845034 Active Cleared 18 Mar 1985

• Ionosit Base Liner

  Class II

  FDA 510(k) K935689 Active Cleared 21 Jan 1994

• Zenith Total Etch 10% Phosphoric Acid

  Class II

  FDA 510(k) K935032 Active Cleared 18 Jan 1994

• Foremost Dentin Adhesive

  Class II

  FDA 510(k) K845033 Active Cleared 18 Mar 1985

• Honigum Automix Impression Material (Foil Bags) and Honigum Quick Impression Material (Cartridges)

  Class II

  FDA 510(k) K980963 Active Cleared 11 May 1998

• Ionosit Seal

  Class II

  FDA 510(k) K954867 Active Cleared 8 Mar 1996

See all devices from Foremost Dental Mfg., Inc. →