Powderlite

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760369 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• X-Ray Unit, Dental Diagnostic

  Class II

  FDA 510(k) K760323 Active Cleared 3 Aug 1976

• Chair, Dental Operative

  Not classified

  FDA 510(k) K760321 Active Cleared 3 Aug 1976

• Podiatry X-Ray Unit

  Not classified

  FDA 510(k) K827816 Active Cleared 24 Aug 1982

• Dental Burs

  Class I

  FDA 510(k) K770093 Active Cleared 24 Jan 1977

• Characterizer Kit Visible Light Cured Restor-Color

  Class II

  FDA 510(k) K852744 Active Cleared 16 Aug 1985

• Alginate Impression Material

  Class II

  FDA 510(k) K771938 Active Cleared 2 Nov 1977

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