FDA 510(k) Application Details - K243731

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K243731
Device Name	Implant, Endosseous, Root-Form
Applicant	P&A USA 7535 Little River Turnpike Suite 310F Annadale, VA 22003 US Other 510(k) Applications for this Company
Contact	Jung Shin Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2024
Decision Date	07/09/2025
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