Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (K240240)
Description
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems by Prismatik Dentalcraft, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240240
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. Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (K240240) cites 10 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProAc... | Prismatik Dentalcraft, Inc. | 2023 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materi... | 2020 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | 2019 |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Impl... | Prismatik Dentalcraft, Inc. | 2019 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic ... | Institut Straumann AG | 2018 |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 |
| K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materi... | 2017 |
| K160979 | Inclusive Abutments | Prismatik Dentalcraft, Inc. | 2016 |
| K083192 | INCLUSIVE TITANIUM ABUTMENT BLANKS | Inclusive Dental Solutions | 2009 |
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX... | Lifecore Biomedical, Inc. | 2005 |
Trace the full predicate network for K240240
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.