Home / 510(k) Clearances / K232099

510(k) K232099

Neodent Implant System - GM Zygomatic Implant System by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2023
Date Received
July 13, 2023
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 JJGC Indústria e Comércio de Materiais Dentários S.A.

  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K250271 — Neodent Implant System - Zirconia Implant System (August 18, 2025)
  • K241492 — Guided Surgery Kit Cases (August 23, 2024)
  • K233857 — Neodent Implant System – Custom Abutments (May 2, 2024)
  • K231803 — Neodent Implant System - Zirconia Implant System (December 13, 2023)
  • K230804 — Complement Kit Cases (July 7, 2023)
  • K214051 — Neodent Implant System-Helix NGM Compact Surgical Kit Cases (April 13, 2022)
  • K203309 — NUVO CF Implant System (July 6, 2021)

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)