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510(k) K223535

SMARTbase Abutment System by Implant Direct Sybron Manufacturing, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2023
Date Received
November 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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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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