FDA 510(k) Application Details - K233356

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K233356
Device Name	Aligner, Sequential
Applicant	Laxmi Dental Export PVT. LTD Survey no. 201/1, Village Gundale Palghar 401501 IN Other 510(k) Applications for this Company
Contact	Sameer Merchant Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	08/08/2024
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