510(k) K854855

PROOF ALGINATE IMPRESSION MATERIAL by Sybron Corp. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1986
Date Received
December 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type