510(k) K231347
K231347 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "BruxZir TintEFX Coloring Liquid". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2023
- Date Received
- May 9, 2023
- 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