FDA 510(k) Application Details - K240538

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K240538
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury, OH 43447 US Other 510(k) Applications for this Company
Contact	Paige Johnson Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2024
Decision Date	07/19/2024
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