ASI Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
3
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0545-2014Class IISEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained deNovember 5, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K123139ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIESMarch 28, 2013
K110481TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASEApril 5, 2012
K974488AIRPREP SYSTEM - MODEL 9001May 26, 1998
K974487SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020February 18, 1998
K932873SEAC MOBILE UNIT BY ASI MEDICALMarch 7, 1994