Additive Manufacturing Zirconia Customized Restoration (K240586)
Description
Additive Manufacturing Zirconia Customized Restoration by Hangzhou Thales Medtech Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240586
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. Additive Manufacturing Zirconia Customized Restoration (K240586) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022 |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016 |
Trace the full predicate network for K240586
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.