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510(k) K240232

EK D3.3 and Ultra Wide Implants by Hiossen, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
January 29, 2024
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 Hiossen, Inc.

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  • K233389 — EK Digital Abutments (May 29, 2024)
  • K222636 — ET Abutment System (April 28, 2023)
  • K203360 — EK Implants and Abutments System (January 7, 2022)
  • K191751 — EM Provisional (December 16, 2019)
  • K191201 — EM SA Implant System (November 15, 2019)
  • K183242 — ET IV SA Dental Implants (May 21, 2019)
  • K180527 — IS3 (May 16, 2018)
  • K170421 — ET Hybrid Abutment (January 11, 2018)

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