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510(k) K000357

EZ CONNECT RESIN by Kerr Dental Materials Center — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2000
Date Received
February 4, 2000
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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  • K013325 — POINT 4 FLOWABLE 2 (October 23, 2001)
  • K011908 — OPTIBOND SOLO PLUS 3 (September 6, 2001)

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