510(k) K932759

TEMPOARY POLYCARBONATE CROWNS by South American Dental Exporting Corp. — Product Code ELZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1994
Date Received
June 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown, Preformed
Device Class
Class I
Regulation Number
872.3330
Review Panel
DE
Submission Type