510(k) K250267
K250267 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)". The FDA issued a decision of Substantially Equivalent on March 14, 2025. 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 14, 2025
- Date Received
- January 30, 2025
- 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