Class Class II
Ensmile (K222619)
Description
Ensmile by Ensmile Pvt, Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222619
Clearance Date2023-03-16
Clearance TypeTraditional
Product CodeNXC
Regulation Number872.5470
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222619
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. Ensmile (K222619) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081960 | INVISALIGN SYSTEM | Align Technology | 2008 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233544 | MESHEET | Dentis Co., Ltd. | 2024 |
Trace the full predicate network for K222619
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.