Class Class II
DD Solid Connect® CAD/CAM Abutments (K191111)
Description
DD Solid Connect® CAD/CAM Abutments by Dental Direkt GmbH, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK191111
Clearance Date2023-01-11
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K191111
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. DD Solid Connect® CAD/CAM Abutments (K191111) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2021 |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Impl... | Prismatik Dentalcraft, Inc. | 2019 |
| K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Med... | Medentika GmbH | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223663 | SIMDA Abutment | Simda Co., Ltd. | 2023 |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CU... | Dental Direkt GmbH | 2023 |
Trace the full predicate network for K191111
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.