510(k) K222445
K222445 is an FDA 510(k) premarket notification submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH for the device "LC ChromeFlow". The FDA issued a decision of Substantially Equivalent on March 6, 2023. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. S&C Polymer Silicon- Und Composite Spezialitaten GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2023
- Date Received
- August 15, 2022
- 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