510(k) K253053
K253053 is an FDA 510(k) premarket notification submitted by Hangzhou SHINING3D Dental Technology Co., Ltd. for the device "Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)". The FDA issued a decision of Substantially Equivalent on September 23, 2025. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Hangzhou SHINING3D Dental Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2025
- Date Received
- September 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type