510(k) K170873
K170873 is an FDA 510(k) premarket notification submitted by Swissmeditec GmbH for the device "Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl". The FDA issued a decision of Substantially Equivalent on Oct 2, 2017. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2017
- Date Received
- Mar 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type
- 510(k)