FDA 510(k) Application Details - K210347

Device Classification Name	Driver, Wire, And Bone Drill, Manual   More FDA Info for this Device
510(K) Number	K210347
Device Name	Driver, Wire, And Bone Drill, Manual
Applicant	3D Systems 5381 South Alkire Circle Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Scott Brewer Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2021
Decision Date	04/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review