Class Class I
Star E900 Handpiece Series (K240183)
Description
Star E900 Handpiece Series by Dentalez, Inc., Stardental Division, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK240183
Clearance Date2024-09-19
Clearance TypeTraditional
Product CodeEGS
Regulation Number872.4200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240183
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. Star E900 Handpiece Series (K240183) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubr... | Dentalez, Inc. | 2020 |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SAN... | Scican GmbH | 2014 |
Trace the full predicate network for K240183
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.