Class Class II
Provata Implant System (K222457)
Description
Provata Implant System by Southern Implants (Pty), Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222457
Clearance Date2023-03-06
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222457
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Provata Implant System (K222457) cites 6 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 |
| K191250 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | 2019 |
| K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 |
| K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies , Ltd. | 2018 |
| K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | 2024 |
| K232418 | Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. | 2023 |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE ... | Southern Implants (Pty), Ltd. | 2023 |
Trace the full predicate network for K222457
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.