Strung Dental Rolls

• • Terminated Z-1799-2016 FDA Class II ·initiated 31 Mar 2016

  Product packaging defective compromising sterility

510(k) Number

K872810 ↗

FDA Product Code

EFN

Device Class

Class I

Regulation

21 CFR Part 872.6050

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Gauze Cherry Sponge

  Class I

  FDA 510(k) K872809 Active Cleared 4 Aug 1987

• Strung Telfa Non-Adherent Sponge

  Class II

  FDA 510(k) K904514 Active Cleared 27 Mar 1991

• Non-Woven Tracheotomy Sponge

  Class I

  FDA 510(k) K872807 Active Cleared 4 Aug 1987

• Suction Tube Tip Fits Over Bussie Frazier Tube

  Class I

  FDA 510(k) K872906 Active Cleared 11 Aug 1987

• Cotton Neurological Sponge

  Class II

  FDA 510(k) K854713 Active Cleared 20 Mar 1986

• Polyester Sponge Pattie

  Class II

  FDA 510(k) K862494 Active Cleared 30 Jul 1986

See all devices from American Silk Sutures, Inc. →