Class Class II

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053)

K253053 2025-09-23 Traditional
Home/ Devices/ Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053)

Description

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) by Hangzhou SHINING3D Dental Technology Co., Ltd., an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253053
Clearance Date2025-09-23
Clearance TypeTraditional
Product CodeEBF
Regulation Number872.3690

Categories

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Predicate lineage for K253053

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. Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053) cites 0 predicate devices and is itself cited by 1 later device.

Later devices that cite this one as their predicate

Devices that cite K253053
K numberDeviceApplicantYear
K261356Dura-CrownHangzhou SHINING3D Dental Technolog...2026

Trace the full predicate network for K253053

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.

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