Home / 510(k) Clearances / K251232

510(k) K251232

MegaGen Zygoma Dental Implant System by Megagen Implant Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
April 22, 2025
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 Megagen Implant Co., Ltd.

  • K242030 — MegaGen Dental Implant Abutment (January 13, 2025)
  • K241972 — BLUEDIAMOND IMPLANT (December 27, 2024)
  • K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (September 18, 2024)
  • K240754 — N2 (March 21, 2024)
  • K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Tem (January 22, 2024)
  • K231967 — ARi ExCon Implant System (December 7, 2023)
  • K223909 — R2GATE Lite TM (October 20, 2023)
  • K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional (October 11, 2023)
  • K223339 — Bone Chamber Implant (July 18, 2023)
  • K211556 — N2 (April 5, 2023)

Other clearances for product code DZE

  • K250806 — Dental Implant System (June 18, 2026)
  • K260006 — INOSS System (June 17, 2026)
  • K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implan (May 12, 2026)
  • K252031 — Adin Long Dental Implant System (March 23, 2026)
  • K253334 — ZENEX Implant System_Short (R-System) (March 16, 2026)
  • 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)