Class Class II

Neodent Implant System – Helix Short Surgical Kit Cases (K223662)

K223662 2023-04-20 Traditional
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Description

Neodent Implant System - Helix Short Surgical Kit Cases by Jjgc Industria E Comercio DE Materiais Dentarios S.A., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223662
Clearance Date2023-04-20
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850

Categories

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Predicate lineage for K223662

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. Neodent Implant System – Helix Short Surgical Kit Cases (K223662) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materi...2019

Later devices that cite this one as their predicate

Devices that cite K223662
K numberDeviceApplicantYear
K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materi...2024

Trace the full predicate network for K223662

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.

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