Class Class II
Parkell Pit and Fissure Sealant (K243254)
Description
Parkell Pit and Fissure Sealant by Parkell, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243254
Clearance Date2025-08-08
Clearance TypeAbbreviated
Product CodeEBC
Regulation Number872.3765
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243254
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. Parkell Pit and Fissure Sealant (K243254) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161580 | Premier Sealant | Premier Dental Company Products | 2016 |
Trace the full predicate network for K243254
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.