Class Class II

Neodent Implant System – Zirconia Implant System (K250271)

K250271 2025-08-18 Traditional
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Description

Neodent Implant System - Zirconia Implant System by JJGC Indústria e Comércio de Materiais Dentários S.A., an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250271
Clearance Date2025-08-18
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640

Categories

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Predicate lineage for K250271

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 – Zirconia Implant System (K250271) cites 9 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materi...2023
K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materi...2023
K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materi...2021
K202942Straumann 4 mm Short ImplantsStraumann USA, LLC2021
K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materi...2020
K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materi...2019
K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materi...2016
K123022NEODENT IMPLANT SYSTEMJjgc Industria E Comercio DE Materi...2013
K101945NEODENT IMPLANT SYSTEMJjgc Industria E Comercio DE Materi...2011

Trace the full predicate network for K250271

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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