Class Class II
BracePaste Fluoride Sealant (K242537)
Description
BracePaste Fluoride Sealant by American Orthodontics Corp., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242537
Clearance Date2024-08-27
Clearance TypeTraditional
Product CodeDYH
Regulation Number872.3750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242537
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. BracePaste Fluoride Sealant (K242537) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K090355 | OPAL SEAL | Ultradent Products, Inc. | 2009 |
Trace the full predicate network for K242537
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.