FDA.reportPublic FDA data

510(k) K240187

Device
Tapered Pro Conical Implant System
Applicant
BioHorizons Implant Systems, Inc.
510(k) number
K240187
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-05
Date received
2024-01-24
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jared Cooper
Address
2300 Riverchase Center Birmingham AL US 35244 35244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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