Class Class II
TruAbutment DS; TruBase (K241485)
Description
TruAbutment DS; TruBase by Truabutment, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241485
Clearance Date2024-10-09
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241485
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. TruAbutment DS; TruBase (K241485) cites 12 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 den... | Implant Direct Sybron Manufacturing... | 2020 |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems, Inc. | 2015 |
| K130999 | OSSEOSPEED PROFILE EV | Dentsply Implants Manufacturing GmbH | 2013 |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | Biomet 3i | 2013 |
| K123664 | INCORIS ZI | Sirona Dental Systems GmbH | 2013 |
| K113779 | CONELOG IMPLANT SYSTEM | Altatec GmbH | 2012 |
| K120414 | OSSEOSPEED PLUS | Astra Tech AB | 2012 |
| K100756 | MALTA | 3M Espe AG Dental Products | 2010 |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2010 |
| K083561 | NEOSS PROACTIVE IMPLANT | Neoss, Ltd. | 2009 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | 2025 |
| K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | 2024 |
Trace the full predicate network for K241485
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.