510(k) K241673
K241673 is an FDA 510(k) premarket notification submitted by Shenzhen Piocreat 3D Technology Co., Ltd. for the device "Denture Base Resin (PN-Denture (Red, White))". The FDA issued a decision of Substantially Equivalent on October 15, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2024
- Date Received
- June 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type