Rotary Scaler

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K782007 ↗

FDA Product Code

ELB

Device Class

Class II

Regulation

21 CFR Part 872.4840

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Alarm Sys for Nitrous Oxide Sys.

  Class I

  FDA 510(k) K771246 Active Cleared 15 Jul 1977

• Cement, Dental/Cavity Liner

  Class II

  FDA 510(k) K781281 Active Cleared 21 Aug 1978

• High Speed Cereamic Bearing Turbine Handpieces

  Class I

  FDA 510(k) K905155 Active Cleared 13 Feb 1991

• Core Material

  Class II

  FDA 510(k) K771247 Active Cleared 15 Jul 1977