Class Class II
Apex Flex (K250617)
Description
Apex Flex by Sprintray, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250617
Clearance Date2025-04-29
Clearance TypeTraditional
Product CodeEBI
Regulation Number872.3760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250617
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. Apex Flex (K250617) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212448 | NightGuard Flex | Sprintray, Inc. | 2021 |
| K072402 | FLEX-STAR V | Cmp Industries, LLC | 2007 |
| K053060 | TCS UNBREAKABLE | Thermoplastic Comfort Systems, Inc. | 2006 |
Trace the full predicate network for K250617
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.