Class Class II

Neodent Implant System – Custom Abutments (K250614)

K250614 2025-05-27 Traditional
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Description

Neodent Implant System - Custom Abutments by Jjgc Indústria E Comércia DE Materiais Dentários S.A., an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250614
Clearance Date2025-05-27
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630

Categories

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Predicate lineage for K250614

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 – Custom Abutments (K250614) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materi...2024
K182620MRI Compatibility for Existing Neodent Implant SystemJjgc Industria E Comercio DE Materi...2019
K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materi...2017

Trace the full predicate network for K250614

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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