Primescan 2
Primescan 2 Ref
1manufacturer
1catalogue number
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 | Sirona Dental Systems Gmbh, Germany |
|---|---|
| FDA product code | NBL |
| Device type | Light-Induced Fluorescence Caries Detector |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1745 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6808203 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Sopro | 13 |
| Trios | 3SHAPE Trios A/S | 6 |
| 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 |
| 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
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.