Class Class II
DHX-70H, XTG-70H (K221587)
Description
DHX-70H, XTG-70H by Digimed Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221587
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeEHD
Regulation Number872.1800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221587
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. DHX-70H, XTG-70H (K221587) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K132041 | REXTAR X | Meta Biomed, Inc. | 2013 |
Trace the full predicate network for K221587
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.