510(k) K143104
K143104 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X". The FDA issued a decision of Substantially Equivalent on March 25, 2015. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2015
- Date Received
- October 29, 2014
- 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