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510(k) K905131

DURAFILL COLOR VS by Kulzer, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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