510(k) K223173

Proxeo ULTRA (PB-510, PB-520 and PB-530) by W&H Dentalwerk Buermoss GmbH — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2023
Date Received
October 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type