Fluorescence Mode
Fluorescence Mode is a built-in accessory function for the Zeiss Extaro 300 dental surgical microscope. It uses narrow-band violet-blue illumination around 405 nm as an aid in detecting…
Fluorescence Mode is a built-in accessory function for the Zeiss Extaro 300 dental surgical microscope. It uses narrow-band violet-blue illumination around 405 nm as an aid in detecting dental caries.
The function adds a light source, a bandpass filter in the microscope head and a multifunction control knob. The dentist views the illuminated tooth through the microscope’s magnifying optics.
Microscope Integration
The underlying microscope provides variable magnification, illumination and positioning of the surgical view. Its firmware controls the light source, filter and video functions. Fluorescence Mode operates within that optical system and is not a standalone imaging device.
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 | Carl Zeiss Suzhou Co., Ltd., China |
|---|---|
| FDA product code | NBL |
| Device type | Light-Induced Fluorescence Caries Detector |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1745 |
| Establishment | Manufacturer |
| 510(k) | K171007 |
| Record published | 2018-09-25 |
| Record revised | 2026-07-23 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000-2165-387 | 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 |
| Primescan 2 | Sirona Dental Systems Gmbh | 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 |
|---|---|
| K171007 | 2018-05-03 |
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.