Class Class I
ELEC Master, ELEC Master Dual (K202963)
Description
ELEC Master, ELEC Master Dual by Mgnewton , Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK202963
Clearance Date2023-05-05
Clearance TypeTraditional
Product CodeEIA
Regulation Number872.6640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K202963
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. ELEC Master, ELEC Master Dual (K202963) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017 |
Trace the full predicate network for K202963
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.