Class Class II
LONGY Implant and LONGY-N Implant (K241462)
Description
LONGY Implant and LONGY-N Implant by Noris Medical , Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241462
Clearance Date2025-02-11
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241462
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. LONGY Implant and LONGY-N Implant (K241462) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materi... | 2019 |
| K190718 | Zygomatic Implants | Jjgc Industria E Comercio DE Materi... | 2019 |
| K153043 | Noris Medical MBI Dental Implant System | Noris Medical , Ltd. | 2016 |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical , Ltd. | 2016 |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | Noris Medical , Ltd. | 2014 |
Trace the full predicate network for K241462
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.