Class Class II
Luna Dental Implant System (K223395)
Description
Luna Dental Implant System by Shinhung Mst Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223395
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223395
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. Luna Dental Implant System (K223395) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161435 | Temporary Snap Abutment | Nobel Biocare AB | 2016 |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2016 |
| K123155 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2013 |
| K120847 | ET/SS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012 |
Trace the full predicate network for K223395
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.