Trios
6 catalogue numbers from TSL-01, listed by 3SHAPE Trios A/S, Denmark, under Light-Induced Fluorescence Caries Detector. 1 manufacturer in China is registered for this product code.
1manufacturer
6catalogue 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 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, 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 |
| Packaging | Pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSL-01 | In distribution | |
| TST-11 | In distribution | |
| LP1-2 | In distribution | |
| C2BP | In distribution | |
| TB-04 | In distribution | |
| TST-13 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Sopro | 13 |
| Trios 5 | 3SHAPE Trios A/S | 3 |
| 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.