Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (K222836)
Description
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs by Institut Straumann AG, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222836
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. Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (K222836) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020 |
| K190082 | Straumann BLX Variobase Abutment | Institut Straumann AG | 2019 |
| K170050 | Z-CAD smile | Metoxit AG | 2018 |
| K170356 | Straumann Variobase Abutments | Institut Straumann AG | 2017 |
| K120822 | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VAR... | Institut Straumann AG | 2012 |
| K072569 | METOXIT CAM-BLANKS | Metoxit AG | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | Anthogyr | 2024 |
Trace the full predicate network for K222836
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.