Ortholux Visible Light Curing Unit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880392 ↗

FDA Product Code

EBZ

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Debracketing Instrument

  Class I

  FDA 510(k) K924295 Active Cleared 23 Nov 1992

• Tongue Holder/Saliva Ejector

  Class I

  FDA 510(k) K800210 Active Cleared 6 Feb 1980

• Nonstaining Alastiks

  Class I

  FDA 510(k) K910288 Active Cleared 29 Mar 1991

• Transcend Series 6000 Debonding Instruments

  Class I

  FDA 510(k) K924645 Active Cleared 25 Nov 1992

• Adhesive Precoated Brackets

  Class II

  FDA 510(k) K911271 Active Cleared 29 May 1991

• Unitek Disposable Impression Syringe

  Class I

  FDA 510(k) K851386 Active Cleared 29 Apr 1985

See all devices from Unitek Corp. →