Class Class II
STR8 Clear Aligner (K223141)
Description
STR8 Clear Aligner by Str8 Oral Care, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223141
Clearance Date2023-04-24
Clearance TypeTraditional
Product CodeNXC
Regulation Number872.5470
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223141
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. STR8 Clear Aligner (K223141) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | 2024 |
Trace the full predicate network for K223141
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.