Home / 510(k) Clearances / K173819

510(k) K173819

MyPlant II Implant System by Hager& Meisinger GmbH — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2018
Date Received
December 18, 2017
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 Hager& Meisinger GmbH

  • K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (September 29, 2025)
  • K240321 — MP Pin flat without thread (36BMP000020/MP20) (October 17, 2024)
  • K201210 — The Micro Screw System, Micro Screw System Basic (October 8, 2021)
  • K180360 — OKTAGON Implant System (May 10, 2018)
  • K170287 — Dental Implants OKTAGON Bone Level Tapered Design (May 24, 2017)
  • K162073 — Dental Implants OKTAGON Tissue Level and Bone Level (February 24, 2017)
  • K160132 — Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON B (November 21, 2016)
  • K143539 — Dental Implant OKTAGON Bone Level (August 31, 2015)
  • K132214 — ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIG (July 7, 2014)
  • K122807 — DENTAL IMPLANT SYSTEM (June 13, 2014)

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)