510(k) K250969
K250969 is an FDA 510(k) premarket notification submitted by Dent4you AG for the device "JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Dent4you AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2025
- Date Received
- March 31, 2025
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type