Class Class II
Glass Ceramic (K223194)
Description
Glass Ceramic by Shenzhen Xiangtong Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223194
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223194
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. Glass Ceramic (K223194) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SE... | Liaoning Upcera Co., Ltd. | 2014 |
| K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, Inc. | 2005 |
| K051170 | GEMINI GXL | Philips Medical Systems (Cleveland)... | 2005 |
Trace the full predicate network for K223194
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.