Class Class II
TRI-matrix® X-Force Implants (K242661)
Description
TRI-matrix® X-Force Implants by Tri Dental Implants Int. AG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242661
Clearance Date2025-01-08
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242661
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. TRI-matrix® X-Force Implants (K242661) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023 |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Im... | Blue Sky Bio, LLC | 2022 |
| K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | 2021 |
| K151916 | TRI Dental Implant System | Tri Dental Implants Int. AG | 2015 |
Trace the full predicate network for K242661
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.