Class Class II
Guided Surgery Kit Cases (K241492)
Description
Guided Surgery Kit Cases by JJGC Indústria e Comércio de Materiais Dentários S.A., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241492
Clearance Date2024-08-23
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241492
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. Guided Surgery Kit Cases (K241492) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materi... | 2023 |
| K203618 | Neodent EasyGuide Kit Cases | Jjgc Industria E Comercio DE Materi... | 2021 |
| K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materi... | 2019 |
Trace the full predicate network for K241492
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.