510(k) K833955

NOVEL DISPENSER/PACKAGE by Dentsply Intl. — Product Code EIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
November 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Filling, Plastic, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type