510(k) K253191
K253191 is an FDA 510(k) premarket notification submitted by Dental Creativ Management GmbH for the device "DCMhotbond zircon". The FDA issued a decision of Substantially Equivalent on May 21, 2026. 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 21, 2026
- Date Received
- September 26, 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