Class Class II
S.I.N. Dental Implant System (K251046)
Description
S.I.N. Dental Implant System by S.I.N. Implant System Ltda, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251046
Clearance Date2025-08-13
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251046
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. S.I.N. Dental Implant System (K251046) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacion... | 2022 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materi... | 2020 |
| K170392 | S.I.N. Implant System | S.I.N. Sistema DE Implante Nacion... | 2017 |
| K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materi... | 2015 |
Trace the full predicate network for K251046
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.