510(k) K912417

MOLAR DISTALIZING ASSEMBLY by American Orthodontics — Product Code DYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1991
Date Received
May 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retainer, Screw Expansion, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type