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510(k) K202524

Standard Sterilizable Tray by Implant Direct Sybron Manufacturing, LLC — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2021
Date Received
September 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K191458 — Legacy SMARTBase Abutments (October 10, 2019)
  • K181359 — InterActive SMARTBase Abutments (August 15, 2018)

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