Class Class II
PMMA Blocks for Dental Use (K223477)
Description
PMMA Blocks for Dental Use by Aidite (Qinhuangdao) Technology Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223477
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeEBG
Regulation Number872.3770
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223477
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. PMMA Blocks for Dental Use (K223477) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co.... | 2020 |
Trace the full predicate network for K223477
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.