Class Class II

Additive Manufacturing (Light Curing) Crown Bridge Resin (K250497)

K250497 2025-04-30 Traditional
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Description

Additive Manufacturing (Light Curing) Crown Bridge Resin by Aidite (Qinhuangdao) Technology Co., Ltd., an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250497
Clearance Date2025-04-30
Clearance TypeTraditional
Product CodeEBF
Regulation Number872.3690

Categories

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Predicate lineage for K250497

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. Additive Manufacturing (Light Curing) Crown Bridge Resin (K250497) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. He...2023
K222877FREEPRINT crownDetax GmbH2022

Trace the full predicate network for K250497

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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