Class Class II
CMFlexTM (K213260)
Description
CMFlexTM by Dimension Inx Corp., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213260
Clearance Date2022-12-30
Clearance TypeTraditional
Product CodeLYC
Regulation Number872.3930
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213260
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. CMFlexTM (K213260) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131385 | EASY-GRAFT | Degradable Solutions AG | 2013 |
| K101827 | OSTEOSCAF | Texas Innovative Medical Devices (D... | 2011 |
Trace the full predicate network for K213260
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.