510(k) K222961
K222961 is an FDA 510(k) premarket notification submitted by Harvest Dental Products, LLC for the device "Harvest Conceal ZR Block Out". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Harvest Dental Products, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2023
- Date Received
- September 27, 2022
- 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