510(k) K183569
K183569 is an FDA 510(k) premarket notification submitted by Dental Direkt GmbH for the device "DD cube ONE ML". The FDA issued a decision of Substantially Equivalent on February 14, 2019. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Dental Direkt GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2019
- Date Received
- December 21, 2018
- 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