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510(k) K172576

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2017
Date Received
August 28, 2017
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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  • K151621 — BioHorizons CAD/CAM Abutments (January 13, 2016)
  • K143022 — BioHorizons Tapered Internal Implants (January 8, 2015)
  • K121787 — BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS (September 5, 2012)

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