Class Class II
Conical Ti Base abutments (K243521)
Description
Conical Ti Base abutments by BioHorizons Implant Systems, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243521
Clearance Date2025-05-01
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243521
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. Conical Ti Base abutments (K243521) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 |
| K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2023 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 |
| K022476 | RELYX RMGIP | 3M Company | 2002 |
Trace the full predicate network for K243521
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.