Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880)
Description
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) by Nakanishi, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241880
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. Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | 2017 |
| K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 |
Trace the full predicate network for K241880
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.