FDA 510(k) Application Details - K110888

Device Classification Name	Heat Source For Bleaching Teeth   More FDA Info for this Device
510(K) Number	K110888
Device Name	Heat Source For Bleaching Teeth
Applicant	DR. FRESH, INC. 12101 CULLEN BLVD HOUSTON, TX 77047-1131 US Other 510(k) Applications for this Company
Contact	M. JOYCE HEINRICH Other 510(k) Applications for this Contact
Regulation Number	872.6475   More FDA Info for this Regulation Number
Classification Product Code	EEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2011
Decision Date	01/12/2012
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