# Hangzhou SHINING3D Dental Technology Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 5 (2025–2026): 5 510(k) clearances
- Product codes: EBF (3), EBI (1), EBG (1)
- 510(k) review time since 2016: median 2 days, against 59 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vertex-Dental B.V.: 1 (https://510kreport.com/company/vertex-dental)
- Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG: 1 (https://510kreport.com/company/bego-bremer-goldschlagerei-wilh-herbst)
- Pro3Dure Medical GmbH: 1 (https://510kreport.com/company/pro3dure-medical)
- Detax GmbH & Co. KG: 1 (https://510kreport.com/company/detax)

## Its most-cited devices
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (2025), cited by 1

## Recent decisions
- K261356: Dura-Crown (Apr 27, 2026)
- K261261: Dura-Arch (Apr 17, 2026)
- K260170: LumiCera (Jan 21, 2026)
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (Sep 23, 2025)
- K250946: Denture Base Resin DT20 (Mar 31, 2025)

Source page: https://510kreport.com/company/hangzhou-shining3d-dental-technology