Class Class II
Alpha Dent Implants Dental Implants System (K240435)
Description
Alpha Dent Implants Dental Implants System by Alpha Dent Implants GmbH, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240435
Clearance Date2024-12-20
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240435
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. Alpha Dent Implants Dental Implants System (K240435) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210499 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | 2021 |
| K200102 | MIS Dental Implant System | Dentsply Sirona | 2020 |
Trace the full predicate network for K240435
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.