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510(k) K161713

Dentium CAD/CAM Abutments by Dentium Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2016
Date Received
June 21, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Dentium Co., Ltd.

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  • K193341 — iCTmotor (WL-1) (September 4, 2020)
  • K192436 — Healing Abutments and Cover Screws (January 23, 2020)
  • K191634 — Scan Abutments and Comfort Caps (November 4, 2019)
  • 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)
  • K160965 — SuperLine (January 13, 2017)
  • K160828 — Dentium Implantium & SuperLine Prosthetics (September 15, 2016)

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  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
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