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510(k) K192221

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts by Implant Direct Sybron Manufacturing, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2020
Date Received
August 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K192218 — Custom Legacy and Custom InterActive Titanium Abutments (May 8, 2020)
  • K191458 — Legacy SMARTBase Abutments (October 10, 2019)
  • K181359 — InterActive SMARTBase Abutments (August 15, 2018)

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