510(k) K182065
K182065 is an FDA 510(k) premarket notification submitted by Blue Dent Dental for the device "EVOLUX CAD/CAM PMMA BLOCKS". The FDA issued a decision of Substantially Equivalent on Dec 13, 2018. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2018
- Date Received
- Aug 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
- 510(k)