Class Class II
Straumann CARES Visual and Nova Dental CAD (K233252)
Description
Straumann CARES Visual and Nova Dental CAD by Institut Straumann AG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233252
Clearance Date2024-12-26
Clearance TypeTraditional
Product CodePNP
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233252
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 CARES Visual and Nova Dental CAD (K233252) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200100 | Abutment Design | 3Shape A/S | 2020 |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020 |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | Institut Straumann AG | 2018 |
| K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM A... | Institut Straumann AG | 2009 |
Trace the full predicate network for K233252
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.