Trios 5
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
1manufacturer
3catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | 3SHAPE Trios A/S, Denmark |
|---|---|
| FDA product code | NBL |
| Device type | Light-Induced Fluorescence Caries Detector |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1745 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K221249 |
| Record published | 2022-09-26 |
| Record revised | 2025-06-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 80 to 110 KiloPascal; Storage environment humidity 10 to 85 % RH; Storage environment temperature 14 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L1-2 | In distribution | |
| L1P-1F | In distribution | |
| L1P-1F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Sopro | 13 |
| Trios | 3SHAPE Trios A/S | 6 |
| Smartooth | Smartooth Co., Ltd. | 2 |
| DIAGNOcam Vision Full HD | Kavo Dental Gmbh | 2 |
| CS 1600 | Carestream Health, Inc. | 1 |
| Primescan 2 | Sirona Dental Systems Gmbh | 1 |
| Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 1 |
| CamX Spectra Handpiece | Dürr Dental SE | 1 |
| Primescan 2 Multiuse Sleeve | Sirona Dental Systems Gmbh | 1 |
| Fluorescence Mode | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 1 |
| Ortek Therapeutics, Inc. | Ortek Therapeutics, Inc. | 1 |
| Aiobio | Aiobio Co., Ltd. | 1 |
Showing 12 of 18. All products under Light-Induced Fluorescence Caries Detector
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242103 | 2025-04-04 |
| K221249 | 2022-09-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.