CEFLA DENTAL GROUP

FDA Regulatory Profile

CEFLA DENTAL GROUP appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1217-2013, Class II) was initiated on August 10, 2012. Its most recent 510(k) clearance was granted on October 21, 2010.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1217-2013Class IIMyRay RXDC dental unit x-ray unitAugust 10, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORSOctober 21, 2010
K101661MYRAY HYPERIONSeptember 16, 2010