Class Class II
Partial Flex (K242897)
Description
Partial Flex by Clemde SA DE CV, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242897
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeEBI
Regulation Number872.3760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242897
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. Partial Flex (K242897) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K053060 | TCS UNBREAKABLE | Thermoplastic Comfort Systems, Inc. | 2006 |
Trace the full predicate network for K242897
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.