Class Class I
TRAUS Air Dental Handpiece (K221741)
Description
TRAUS Air Dental Handpiece by Saeshin Precision Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK221741
Clearance Date2023-02-22
Clearance TypeTraditional
Product CodeEFB
Regulation Number872.4200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221741
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. TRAUS Air Dental Handpiece (K221741) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio... | 2015 |
Trace the full predicate network for K221741
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.