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510(k) K160441

Identic and KromaFaze Alginate Dental Impression Materials by Kerr Corporation — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2016
Date Received
February 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
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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