FDA 510(k) Application Details - K111249

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K111249
Device Name	Handpiece, Air-Powered, Dental
Applicant	ORTHOMATICS, INC. 200 WEST COUNTY LINE ROAD #340 HIGHLANDS RANCH, CO 80129 US Other 510(k) Applications for this Company
Contact	PAUL ROCKE Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2011
Decision Date	02/08/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review