Heated Gutta Percha Delivery System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832654 ↗

FDA Product Code

EKM

Device Class

Class I

Regulation

21 CFR Part 872.3850

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

• Ortholux Visible Light Curing Unit

  Class II

  FDA 510(k) K880392 Active Cleared 7 Apr 1988

• 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

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