Double Bow Tooth Separator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831136 ↗

FDA Product Code

JEP

Device Class

Class I

Regulation

21 CFR Part 872.4565

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ez-On Tubing Conditioner (Lubricant)

  Not classified

  FDA 510(k) K854700 Active Cleared 12 Mar 1986

• Diamond Burs-Handpiece

  Class I

  FDA 510(k) K854691 Active Cleared 25 Mar 1986

• Markley Threaded Wire

  Class I

  FDA 510(k) K830773 Active Cleared 28 Apr 1983

• Balance Articulator

  Class I

  FDA 510(k) K811075 Active Cleared 13 May 1981

• Binocular Loupe

  Class I

  FDA 510(k) K830878 Active Cleared 6 Apr 1983

• Tubing Handpiece Replacement

  Class I

  FDA 510(k) K854697 Active Cleared 6 Mar 1986

See all devices from Almore Intl., Inc. →