510(k) K192153
K192153 is an FDA 510(k) premarket notification submitted by New Stetic, SA for the device "Portux CAD/CAM Disc". The FDA issued a decision of Substantially Equivalent on November 7, 2019. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. New Stetic, SA has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2019
- Date Received
- August 9, 2019
- 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