Class Class II
TempFIT Temporary Crown and Bridge Resin (K251271)
Description
TempFIT Temporary Crown and Bridge Resin by Rizhao Huge Biomaterials Company, Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251271
Clearance Date2025-06-23
Clearance TypeTraditional
Product CodeEBG
Regulation Number872.3770
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251271
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. TempFIT Temporary Crown and Bridge Resin (K251271) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | 2010 |
Trace the full predicate network for K251271
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.