510(k) K771176

GOTHIC ARCH TRACING by Dentsply Intl. — Product Code KZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
June 30, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ink, Arch Tracing
Device Class
Class I
Regulation Number
872.3150
Review Panel
DE
Submission Type