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510(k) K232418

Device
Single Platform SP1 Implant System
Applicant
Southern Implants (Pty), Ltd.
510(k) number
K232418
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-01
Date received
2023-08-11
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
Colin Saffy
Address
1 Albert Rd. Guateng ZA 0062 0062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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