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510(k) K160483

Burn-out Cylinder and Angled Screw Abutments by Dentium Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2016
Date Received
February 22, 2016
Clearance Type
Abbreviated
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.

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  • K172640 — Dentium Implantium & SuperLine Prosthetics (May 14, 2018)
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  • K171126 — Implantium II (September 7, 2017)
  • K170384 — Dentium NR Line CAD/CAM Abutments (August 17, 2017)
  • K160965 — SuperLine (January 13, 2017)
  • K161713 — Dentium CAD/CAM Abutments (December 16, 2016)

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