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510(k) K014144

EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 by Afp Imaging Corp. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2002
Date Received
December 18, 2001
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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