The following data is part of a premarket notification filed by 3shape Trios A/s with the FDA for L1p-1f (trios 5).
| Device ID | K221249 |
| 510k Number | K221249 |
| Device Name: | L1P-1F (TRIOS 5) |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | 3Shape TRIOS A/S Holmens Kanal 7 Copenhagen K, DK Dk-1060 |
| Contact | Klaus Rudbaek Hoj |
| Correspondent | Klaus Rudbaek Hoj 3Shape TRIOS A/S Holmens Kanal 7 Copenhagen K, DK Dk-1060 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05902729753784 | K221249 | 000 |
| 05902729753777 | K221249 | 000 |
| 05902729753760 | K221249 | 000 |
| 05902729753739 | K221249 | 000 |
| 05902729753722 | K221249 | 000 |
| 05902729753685 | K221249 | 000 |
| 05902729753678 | K221249 | 000 |
| 05902729753746 | K221249 | 000 |