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510(k) K222144

IR SLA Type Implant System by Biotem Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2023
Date Received
July 20, 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

Other clearances by Biotem Co., Ltd.

  • K222142 — BR SLA Type Implant System (June 24, 2023)
  • K190641 — AR_N SLA Type Implant System (February 21, 2020)
  • K171179 — BR Type Implant System (February 9, 2018)
  • K171297 — AR_N Type Implant System (January 31, 2018)
  • K171185 — IR Type Implant System (December 1, 2017)

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