Class Class II
ISO Abutment (K241183)
Description
ISO Abutment by Seum Medi Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241183
Clearance Date2025-07-28
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241183
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. ISO Abutment (K241183) cites 12 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019 |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | 2018 |
| K161103 | US SA Implant System | Osstem Implant Co., Ltd. | 2017 |
| K160965 | SuperLine | Dentium Co., Ltd. | 2017 |
| K160536 | Chaorum Implant System | Medimecca Co., Ltd. | 2017 |
| K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015 |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | Megagen Implant Co., Ltd. | 2014 |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012 |
| K112787 | KERATOR | Kj Meditech Co., Ltd. | 2012 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2007 |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | Implant Innovations, Inc. | 2007 |
Trace the full predicate network for K241183
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.