Class Class II
MIS LYNX Conical Connection Implant System (K251297)
Description
MIS LYNX Conical Connection Implant System by Dentsply Sirona, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251297
Clearance Date2025-07-24
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251297
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. MIS LYNX Conical Connection Implant System (K251297) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024 |
| K200102 | MIS Dental Implant System | Dentsply Sirona | 2020 |
| K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies , Ltd. | 2018 |
Trace the full predicate network for K251297
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.