510(k) K042769

ADSEAL ROOT CANAL SEALER by Meta Biomed Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
October 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type