Potassium Nitrate-Zinc Oxide Eugenol Temp. Dental

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895988 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Potassium Nitrate Polycarboxylate Dental Cement

  Class II

  FDA 510(k) K882417 Active Cleared 13 Feb 1989

• Desens-Ionomer

  Class II

  FDA 510(k) K032175 Active Cleared 9 Oct 2003

• Glass Ionomer Cement

  Class II

  FDA 510(k) K925207 Active Cleared 8 Jul 1993

• Potassium Nitrate Composite Restoration Pit and

  Class II

  FDA 510(k) K905582 Active Cleared 29 Apr 1991

• Composite Restoration Material

  Class II

  FDA 510(k) K031721 Active Cleared 11 Sep 2003

• Modification to Potassium Nitrate-Polycarboxylate Dental Cement

  Class II

  FDA 510(k) K022025 Active Cleared 15 Aug 2002