Mouthguard and Aligner Materials

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K062828 ↗

FDA Product Code

MQC

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Disposable Screw Type Prophy Brush

  Class I

  FDA 510(k) K900507 Active Cleared 10 Apr 1990

• Sterile Flexofile Files and Instruments

  Class I

  FDA 510(k) K971606 Active Cleared 3 Jun 1997

• Delton F Pit & Fissure Sealant

  Class II

  FDA 510(k) K951296 Active Cleared 3 May 1995

• Fluoride Varnish

  Class II

  FDA 510(k) K031932 Active Cleared 15 Sep 2003

• Dentsply Cavitron Sps Scaler System

  Class II

  FDA 510(k) K970123 Active Cleared 11 Apr 1997

• Delton Fs Direct Delivery System

  Class II

  FDA 510(k) K982564 Active Cleared 6 Oct 1998

See all devices from Dentsply Intl. →