Class Class II
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (K231338)
Description
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment by 3M Espe Dental Products, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231338
Clearance Date2023-05-10
Clearance TypeTraditional
Product CodeLBH
Regulation Number872.3260
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231338
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. 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (K231338) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131487 | FLUOR PROTECTOR S | Ivoclar Vivadent, AG | 2014 |
| K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | 3M Espe Dental Products | 2010 |
Trace the full predicate network for K231338
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.