510(k) K051953

EVERSTICK A&O by Stick Tech , Ltd. — Product Code DYW

K051953 is an FDA 510(k) premarket notification submitted by Stick Tech , Ltd. for the device "EVERSTICK A&O". The FDA issued a decision of Substantially Equivalent on March 21, 2006. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Stick Tech , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2006
Date Received
July 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type