FDA.reportPublic FDA data

510(k) K243078

Device
HexaPLUS S OneDrill Implant System
Applicant
Osseofuse International, Inc.
510(k) number
K243078
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-10
Date received
2024-09-30
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
Priscilla Chung
Address
6170 W. Desert Inn Rd. Suite B Las Vegas NV US 89146 89146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
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