New Base for Orthodontic Appliances

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771774 ↗

FDA Product Code

EJF

Device Class

Class I

Regulation

21 CFR Part 872.5410

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ion-Implanted Neo Sentalloy

  Class I

  FDA 510(k) K932025 Active Cleared 13 Sep 1993

• Gac Thumb-Sucking Control Appliance

  Class I

  FDA 510(k) K920850 Active Cleared 24 Aug 1992

• Orthodontic Stainless Steel Bracket

  Class I

  FDA 510(k) K923029 Active Cleared 28 Sep 1992

• Orthodontic Elastomer

  Class I

  FDA 510(k) K932319 Active Cleared 20 Sep 1993

• Smartbond

  Class II

  FDA 510(k) K981036 Active Cleared 5 Apr 1999

• Sentinol -Orthodontic Arch Wire

  Class I

  FDA 510(k) K851055 Active Cleared 9 May 1985

See all devices from Gac Intl., Inc. →