510(k) K240735
K240735 is an FDA 510(k) premarket notification submitted by Bredent GmbH & Co. KG for the device "visio.lign color, visio.lign shield". The FDA issued a decision of Substantially Equivalent on December 12, 2024. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Bredent GmbH & Co. KG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2024
- Date Received
- March 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type