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510(k) K905302

DENTHESIVE by Kulzer, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1991
Date Received
November 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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