Coltene /Whaledent AG

FDA Regulatory Profile

Coltene /Whaledent AG appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2436-2019, Class II) was initiated on July 19, 2019.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Known Names

coltene whaledent, coltene /whaledent

Recent Recalls

NumberClassProductDate
Z-2436-2019Class IIDIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-FJuly 19, 2019