510(k) K250393
K250393 is an FDA 510(k) premarket notification submitted by United Zirconia for the device "ZircaGlow & ZircaGlow HT Zirconia". The FDA issued a decision of Substantially Equivalent on May 12, 2025. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2025
- Date Received
- February 12, 2025
- Clearance Type
- Traditional
- 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