Class Class II
Dynamic TiBase (K243530)
Description
Dynamic TiBase by Talladium España, SL, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243530
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243530
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. Dynamic TiBase (K243530) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 |
| K232151 | Dynamic TiBase | Talladium España, SL | 2023 |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG | 2022 |
| K212108 | Dynamic TiBase | Talladium España, SL | 2021 |
| K112532 | ET II BIO-SA FIXTURE SYSTEM | Hiossen, Inc. | 2012 |
Trace the full predicate network for K243530
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.