KaVo Dental Technologies LLC

FDA Regulatory Profile

KaVo Dental Technologies LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1387-2019, Class II) was initiated on April 29, 2019. Its most recent 510(k) clearance was granted on December 18, 2017.

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1387-2019Class IIDEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-drivApril 29, 2019
Z-1101-2019Class IIcone-beam CT systemDecember 31, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)December 18, 2017