Osseodent Dental Attachments (Non-Angled)

• • Terminated Z-2438-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

510(k) Number

K904228 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Qar Handpiece

  Class I

  FDA 510(k) K904671 Active Cleared 21 Dec 1990

• Dental Hand Instruments

  Class I

  FDA 510(k) K883322 Active Cleared 26 Aug 1988

• Osseodent Surgical Kit

  Class II

  FDA 510(k) K894331 Active Cleared 4 Oct 1989

• Osseotite Irrigation Unit

  Class I

  FDA 510(k) K901600 Active Cleared 21 Jun 1990

• Osseodent Dental Attachment, Igloo Magnet

  Class II

  FDA 510(k) K900275 Active Cleared 19 Apr 1990

• Osseodent(R) Precision Dental Attachments

  Class II

  FDA 510(k) K895463 Active Cleared 28 Mar 1990

See all devices from Collagen Corp. →