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510(k) K222497

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2022
Date Received
August 18, 2022
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

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  • K191054 — Southern Implants MAX Implant System (December 9, 2019)
  • K191250 — Southern Implants PEEK Abutments (December 5, 2019)

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