FDA 510(k) Application Details - K994357

Device Classification Name	Bracket, Metal, Orthodontic   More FDA Info for this Device
510(K) Number	K994357
Device Name	Bracket, Metal, Orthodontic
Applicant	THERMOELASTIC TECHNOLOGIES, INC. 3234 ELLA LN. NEW PORT RICHEY, FL 34655 US Other 510(k) Applications for this Company
Contact	ART WARD Other 510(k) Applications for this Contact
Regulation Number	872.5410   More FDA Info for this Regulation Number
Classification Product Code	EJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/1999
Decision Date	03/14/2000
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