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510(k) K241032

BellaTek Bars by Biomet 3i, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2024
Date Received
April 16, 2024
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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  • K213672 — T3 Pro Implants (March 28, 2022)
  • K212730 — BellaTek Encode Emergence Healing Abutments (December 21, 2021)
  • K192522 — TSV BellaTek Express and BellaTek Flex Abutments (December 9, 2019)
  • K183138 — Certain BellaTek Express and BellaTek Flex Abutments (July 2, 2019)
  • K173374 — TSV BellaTek Encode Healing Abutments (December 13, 2017)
  • K170013 — Eztetic BellaTek Encode Healing Abutments (September 21, 2017)
  • K150571 — 3i T3 Short Implants (November 20, 2015)

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