510(k) K221249
K221249 is an FDA 510(k) premarket notification submitted by 3Shape TRIOS A/S for the device "L1P-1F (TRIOS 5)". The FDA issued a decision of Substantially Equivalent on September 16, 2022. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. 3Shape TRIOS A/S has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type