Desens-Ionomer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K032175 ↗

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

• 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

• Potassium Nitrate-Zinc Oxide Eugenol Temp. Dental

  Class II

  FDA 510(k) K895988 Active Cleared 7 Mar 1990

• 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

• What is the primary use of Desens-Ionomer?

  Desens-Ionomer is a dental cement designed for restorative or adhesive applications within the oral cavity.

• How is this device regulated?

  This device is regulated as a Class II medical device and has received FDA 510(k) clearance under the number K032175.

• Which medical specialty is this device associated with?

  Desens-Ionomer is categorized under the dental specialty and is reviewed by the dental advisory committee.