510(k) K812239

UNITEK PALATAL BAR by Unitek Corp. — Product Code DYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
August 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Maintainer, Space Preformed, Orthodontic
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type