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510(k) K973257

VERSAETCH by Centrix, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1997
Date Received
August 29, 1997
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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