FDA 510(k) Application Details - K232087

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K232087
Device Name	Mouthguard, Prescription
Applicant	Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury, OH 43447 US Other 510(k) Applications for this Company
Contact	Ritika Sharma Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2023
Decision Date	02/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review