Class Class II
Dentsply Sirona Titanium Bases system (K250295)
Description
Dentsply Sirona Titanium Bases system by Dentsply Sirona, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250295
Clearance Date2025-04-30
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250295
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. Dentsply Sirona Titanium Bases system (K250295) cites 11 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241485 | TruAbutment DS; TruBase | Truabutment, Inc. | 2024 |
| K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment... | Dentsply Sirona | 2024 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024 |
| K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments w... | Dentsply Sirona | 2022 |
| K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV... | Dentsply Sirona | 2022 |
| K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | 2022 |
| K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. | 2021 |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | 2020 |
| K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona | 2020 |
| K123664 | INCORIS ZI | Sirona Dental Systems GmbH | 2013 |
| K111421 | SIRONA DENTAL CAD/CAM SYSTEM | Sirona Dental Systems GmbH | 2012 |
Trace the full predicate network for K250295
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.