Class Class II
Straumann InLab Validated Workflow (K243478)
Description
Straumann InLab Validated Workflow by Institut Straumann AG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243478
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243478
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 InLab Validated Workflow (K243478) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233857 | Neodent Implant System Custom Abutments | JJGC Indústria e Comércio de Materi... | 2024 |
| K182620 | MRI Compatibility for Existing Neodent Implant System | Jjgc Industria E Comercio DE Materi... | 2019 |
| K180536 | Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materi... | 2018 |
| K171649 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2018 |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | Straumann USA, LLC | 2015 |
Trace the full predicate network for K243478
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.