Class Class II
Emerald Herbst (K223624)
Description
Emerald Herbst by Island Dental Lab, Inc Dba Emerald Dental, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223624
Clearance Date2023-05-10
Clearance TypeTraditional
Product CodeLRK
Regulation Number872.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223624
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. Emerald Herbst (K223624) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 |
| K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015 |
| K131138 | RESPIRE PINK SERIES - HERBST | Respire Medical | 2013 |
Trace the full predicate network for K223624
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.