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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment

Manufacturer

BioHorizons Implant Systems Inc.

Date Cleared

2024-07-30

(158 days)

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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