FDA 510(k) Application Details - K251196

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K251196
Device Name	Bracket, Plastic, Orthodontic
Applicant	EC Certification Service GmbH Sandgasse 39a Sankt Veit an der Glan 9300 AT Other 510(k) Applications for this Company
Contact	Elisabeth Moschik Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	DYW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2025
Decision Date	04/21/2025
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	Y
Expedited Review