Home / 510(k) Clearances / K192651

510(k) K192651

ZAGA Zygomatic System by Southern Implants (Pty), Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2020
Date Received
September 24, 2019
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 Southern Implants (Pty), Ltd.

  • K232726 — External Hex Implant System (April 1, 2024)
  • K232418 — Single Platform SP1 Implant System (December 1, 2023)
  • K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (August 1, 2023)
  • K222469 — TIB Abutments (April 17, 2023)
  • K222457 — Provata Implant System (March 6, 2023)
  • K222497 — Zaga Zygomatic System (November 9, 2022)
  • K210923 — Southern Implants Instrument Trays (March 2, 2022)
  • K193084 — TIB Abutment System (October 27, 2020)
  • K191054 — Southern Implants MAX Implant System (December 9, 2019)
  • K191250 — Southern Implants PEEK Abutments (December 5, 2019)

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)