An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. I
| Company | Devices | Share |
|---|---|---|
| Alliedstar Medical Equipment Co., Ltd. | 53 | 28% |
| 3Shape Trios A/S | 29 | 15% |
| Dental Imaging Technologies Corporation | 16 | 8% |
| Sirona Dental Systems Gmbh | 13 | 7% |
| Align Technology, Inc. | 11 | 6% |
| Guangdong Launca Medical Device Technology Co., Ltd. | 9 | 5% |
| Ori Inc | 8 | 4% |
| Ziyang Freqty Medical Equipment Co., Ltd. | 7 | 4% |
| Huvitz Co., Ltd. | 6 | 3% |
| Fussen Technology Co., Ltd. | 5 | 3% |
| Changsha Honchon Technology Co., Ltd | 4 | 2% |
| Chengdu Besmile Medical Technology Co., Ltd. | 4 | 2% |
Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Man | 159 |
| NOF | System, optical impression, computer assisted design and man | 16 |
| NBL | Laser, Fluorescence Caries Detection | 12 |
| NTK | Caries Detector, Laser Light, Transmission | 11 |
| QJK | Intraoral Camera | 11 |
| NTK | Caries detector, laser light, transmission | 5 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
192 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraoral optical scanning system", from 27 companies. The largest labeler is Alliedstar Medical Equipment Co., Ltd. with 28% of records.
NOF (System, Optical Impression, Computer Assisted Design And Man), NOF (System, optical impression, computer assisted design and man), NBL (Laser, Fluorescence Caries Detection), NTK (Caries Detector, Laser Light, Transmission)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.