Class Class II
BellaTek Bars (K241032)
Description
BellaTek Bars by Biomet 3i, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241032
Clearance Date2024-07-15
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241032
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. BellaTek Bars (K241032) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Oste... | 2024 |
| K231434 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 |
| K180998 | BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. | 2018 |
| K111853 | ANGLED TAPERED ABUTMENT | Zimmer Dental, Inc. | 2011 |
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | Biomet 3i, Inc. | 2009 |
| K080864 | CAM STRUCTSURE PRECISION MILLED BARS | Biomet 3i, Inc. | 2008 |
Trace the full predicate network for K241032
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.