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FDA 510(k) Application Details - K183018
Device Classification Name
More FDA Info for this Device
510(K) Number
K183018
Device Name
VPro5
Applicant
Propel Orthodontics LLC
394 South Abbott Ave
Milpitas, CA 95035 US
Other 510(k) Applications for this Company
Contact
Bryce Way
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OYH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2018
Decision Date
11/01/2019
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
FDA Source Information for K183018
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