Class Class II
BLUEDIAMOND IMPLANT, Abutment Screw (K211812)
Description
BLUEDIAMOND IMPLANT, Abutment Screw by Megagen Implant Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK211812
Clearance Date2023-01-06
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K211812
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, Abutment Screw (K211812) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022 |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | 2019 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019 |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2012 |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Te... | Megagen Implant Co., Ltd. | 2024 |
Trace the full predicate network for K211812
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.