Ultrasafe Dental Injection System

• • Terminated Z-0444-03 FDA Unclassified (pre-2012) ·initiated 5 Sep 2002

  Package integrity not validated. Sterility not assured.

510(k) Number

K013801 ↗

FDA Product Code

MEG

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ultrasafe Passive Needle Guard

  Class II

  FDA 510(k) K122558 Active Cleared 20 Sep 2012

• Ultrasafe Injection System Model C200 Injector With Needle Guard

  Class II

  FDA 510(k) K972877 Active Cleared 26 Feb 1998

• Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)

  Class II

  FDA 510(k) K011369 Active Cleared 29 May 2001

• Ultrasafe Plus Passive Needle Guard

  Class II

  FDA 510(k) K123743 Active Cleared 26 Mar 2013

• Ultrasafe Model T200 Injector

  Class II

  FDA 510(k) K972900 Active Cleared 26 Feb 1998

• Ultrasafe Injection System Needle Guard, Models B50, B100L, B150, B225, and B300

  Class II

  FDA 510(k) K972878 Active Cleared 30 Oct 1997

See all devices from Safety Syringes, Inc. →