Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1824-2020Class IINexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - February 25, 2020
Z-1721-2019Class IIRegimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting SolutionJuly 13, 2018
Z-2259-2013Class IINX3 Try-In Gel. The product is used as a tooth shade resin material.September 13, 2013
Z-1076-2013Class IIKerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. February 22, 2013