FDA.reportPublic FDA data

510(k) K240232

Device
EK D3.3 and Ultra Wide Implants
Applicant
Hiossen, Inc.
510(k) number
K240232
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-13
Date received
2024-01-29
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
Peter Lee
Address
85 Ben Fairless Dr. Fariless Hills PA US 19030 19030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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