FDA 510(k) Application Details - K233395

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K233395
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Alliage S/A Industrias MΘdico Odontol≤gica Rodovia Abrπo Assed, Km 53 û CEP 14097-500 ûRibeirπo Preto Sao Paulo BR Other 510(k) Applications for this Company
Contact	Daniel Camargo Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2023
Decision Date	01/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review