| K-number | K242103 |
| Device name | TRIOS Ready Tip |
| Applicant | 3Shape TRIOS A/S |
| Product code | NBL |
| Device class | Class II |
| Decision date | Apr 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.1745 |
The TRIOS 5 (L1P-1F) is an intraoral scanner system intended to aid in the diagnosis of dental caries. It uses white and blue (fluorescence) light-emitting diodes to scan teeth and generate 3D colored images, combined with TRIOS Patient Monitoring software for detection of occlusal and surface caries.
The only difference between the subject device and its predicate is the introduction of the TRIOS Ready Tip (TST-15), a single-use tip that serves as an alternative to the existing reusable tip (TST-11). Both tips include a scanner body sleeve to reduce microbial contamination and ease cleaning and disinfection between patients.
ISO 10993-1 (biological evaluation), ISO 14644-1 (cleanrooms and particle concentration), ISO 14698-1 and 14698-2 (biocontamination control), ASTM D3078 and ASTM F1671/F1671M (leak testing), IEC 60601-1 (electrical safety), IEC 62366-1 (usability engineering), and IEC 62471 (photobiological safety of lamps).
The subject device has identical indications for use and function as the predicate device. A risk analysis per ISO 14971 confirmed that introducing the single-use TST-15 tip does not raise different questions of safety and effectiveness compared to the reusable TST-11 tip already cleared. Non-clinical testing validated that adequate risk control measures mitigate identified risks, demonstrating substantial equivalence in terms of safety and effectiveness.
View the full FDA submission: accessdata.fda.gov