510(k) K240183

Star E900 Handpiece Series by Dentalez, Inc., Stardental Division — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type