Class Class II
BLUEDIAMOND IMPLANT (K241972)
Description
BLUEDIAMOND IMPLANT by Megagen Implant Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241972
Clearance Date2024-12-27
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241972
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. BLUEDIAMOND IMPLANT (K241972) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | 2023 |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical , Ltd. | 2022 |
| K213599 | SuperLine | Dentium Co., Ltd. | 2022 |
| K202942 | Straumann 4 mm Short Implants | Straumann USA, LLC | 2021 |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019 |
Trace the full predicate network for K241972
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.