Class Class II
ICX-Implant System (K231566)
Description
ICX-Implant System by Medentis Medical GmbH, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231566
Clearance Date2024-09-05
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231566
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. ICX-Implant System (K231566) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 |
| K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022 |
| K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacion... | 2020 |
| K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materi... | 2017 |
| K133510 | NEODENT IMPLANT SYSTEM | Jj Industria E Comercio DE Materiai... | 2014 |
| K130222 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA, LLC | 2013 |
| K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | Bicon, LLC | 2009 |
Trace the full predicate network for K231566
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.