FDA 510(k) Application Details - K223173

Device Classification Name Scaler, Ultrasonic

  More FDA Info for this Device
510(K) Number K223173
Device Name Scaler, Ultrasonic
Applicant W&H Dentalwerk Buermoss GmbH
Ignaz-Glaser-Strasse 53
Buermoos 5111 AT
Other 510(k) Applications for this Company
Contact Weidler Gerhard
Other 510(k) Applications for this Contact
Regulation Number 872.4850

  More FDA Info for this Regulation Number
Classification Product Code ELC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/11/2022
Decision Date 07/14/2023
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact