510(k) K253973
K253973 is an FDA 510(k) premarket notification submitted by Liaoning Upcera Co., Ltd. for the device "Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series". The FDA issued a decision of Substantially Equivalent on January 9, 2026. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Liaoning Upcera Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2026
- Date Received
- December 11, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type