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510(k) K143022

BioHorizons Tapered Internal Implants by BioHorizons Implant Systems, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
October 21, 2014
Clearance Type
Special
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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  • K223697 — MRI compatibility for existing BioHorizons dental implants and abutments (October 13, 2023)
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  • K172576 — BioHorizons Tapered Short Implants (November 22, 2017)
  • K151621 — BioHorizons CAD/CAM Abutments (January 13, 2016)
  • K121787 — BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS (September 5, 2012)

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