FDA 510(k) Application Details - K230985

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K230985
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Planmeca Oy Asentajankatu 6 Helsinki 00880 FI Other 510(k) Applications for this Company
Contact	Niina Vuorikallas Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2023
Decision Date	12/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review