Home / 510(k) Clearances / K212730

510(k) K212730

BellaTek Encode Emergence Healing Abutments by Biomet 3i, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2021
Date Received
August 30, 2021
Clearance Type
Special
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, LLC

  • K251660 — T3 Pro Implants– ZimVie Packaging System (June 27, 2025)
  • K241753 — Immediate Molar Implants (October 23, 2024)
  • K241032 — BellaTek Bars (July 15, 2024)
  • K220978 — TSX Implants (September 14, 2022)
  • K213672 — T3 Pro Implants (March 28, 2022)
  • 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)

Other clearances for product code NHA

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251515 — Solidex® Ti-Links and Screws (February 10, 2026)
  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K253253 — IPDmilled Blanks (January 22, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K253341 — Custom Abutments AS (December 23, 2025)
  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
  • K252320 — SIMDA Abutments (December 18, 2025)