Class Class II
Immediate Molar Implants (K241753)
Description
Immediate Molar Implants by Biomet 3i, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241753
Clearance Date2024-10-23
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241753
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. Immediate Molar Implants (K241753) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220978 | TSX Implants | Biomet 3i, LLC | 2022 |
| K213672 | T3 Pro Implants | Biomet 3i, LLC | 2022 |
| K210523 | Implanova | Dental Evolutions, Inc. | 2021 |
| K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | 2019 |
| K150571 | 3i T3 Short Implants | Biomet 3i | 2015 |
Trace the full predicate network for K241753
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.