Class Class II
No Stress Impress (K213175)
Description
No Stress Impress by No Stress Impress, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213175
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeELW
Regulation Number872.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213175
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. No Stress Impress (K213175) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K110378 | IMPRESSION COMPOUND | Spofadental | 2011 |
Trace the full predicate network for K213175
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.