Home / 510(k) Clearances / K122300

510(k) K122300

T3 DENTAL IMPLANT by Biomet 3i — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2013
Date Received
July 31, 2012
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

Other clearances by Biomet 3i

  • 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)
  • 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)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)