Class Class II
Straumann® RidgeFit Implants (K250294)
Description
Straumann® RidgeFit Implants by Institut Straumann AG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250294
Clearance Date2025-08-12
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250294
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. Straumann® RidgeFit Implants (K250294) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211052 | Straumann RidgeFit Implants | Institut Straumann AG | 2021 |
| K191895 | Straumann Mini Implants | Institut Straumann AG | 2019 |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB... | Imtec Corp. | 2003 |
Trace the full predicate network for K250294
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.