510(k) K251593
K251593 is an FDA 510(k) premarket notification submitted by Denmat Holding, LLC for the device "DenMat Multilayered Zirconia Disc". The FDA issued a decision of Substantially Equivalent on August 25, 2025. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Denmat Holding, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2025
- Date Received
- May 27, 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