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510(k) K173374

TSV BellaTek Encode Healing Abutments by Biomet 3i — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2017
Date Received
October 27, 2017
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.

Other clearances by Biomet 3i

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  • K220978 — TSX Implants (September 14, 2022)
  • 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)
  • K170013 — Eztetic BellaTek Encode Healing Abutments (September 21, 2017)
  • K150571 — 3i T3 Short Implants (November 20, 2015)

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