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510(k) K230242

Device
OsteoCentric Dental Implant System
Applicant
OsteoCentric Technologies
510(k) number
K230242
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-05
Date received
2023-01-30
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
Todd Evans
Address
75 W. 300 N. Suite 150 Logan UT US 84321 84321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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