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510(k) K213599

SuperLine by Dentium Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2022
Date Received
November 15, 2021
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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  • K172640 — Dentium Implantium & SuperLine Prosthetics (May 14, 2018)
  • K171622 — Dentium Ti-Base (January 11, 2018)
  • K171126 — Implantium II (September 7, 2017)
  • K170384 — Dentium NR Line CAD/CAM Abutments (August 17, 2017)
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  • K161713 — Dentium CAD/CAM Abutments (December 16, 2016)
  • K160828 — Dentium Implantium & SuperLine Prosthetics (September 15, 2016)

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