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510(k) K162257

P1145 Dental Restorative by Kerr Corporation — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2016
Date Received
August 11, 2016
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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  • K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retractio (January 13, 2017)
  • K162436 — EndoVac Pure (December 21, 2016)

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