FDA 510(k) Application Details - K251239

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K251239
Device Name	Material, Tooth Shade, Resin
Applicant	VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven 27472 DE Other 510(k) Applications for this Company
Contact	Katrin Froehlich Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2025
Decision Date	05/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review