FDA 510(k) Application Details - K102561

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K102561
Device Name	Bracket, Ceramic, Orthodontic
Applicant	HT CO., LTD. HBI 527, HANYANG UNIV. 1271 SA 1(IL)-DONG SANGNOK-GU ANSAN-SI, GYEONGGI-DO 426-791 KR Other 510(k) Applications for this Company
Contact	JERRY CHOI Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2010
Decision Date	01/25/2011
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