510(k) K152373
K152373 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH & Co. for the device "VITA VM LC Flow". The FDA issued a decision of Substantially Equivalent on Dec 30, 2015. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Vita Zahnfabrik H.Rauter GmbH & Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 30, 2015
- Date Received
- Aug 21, 2015
- Clearance Type
- Abbreviated
- 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