Prosthetic devices · 21 CFR 872 Subpart D
Color Scanner
FDA device type “Scanner, Color”.
- Companies listing it
- 64 makers
- Brands and models
- 8
- 510(k) clearances
- 20 in five years
- FDA name
- Scanner, Color
510(k) clearances per year, 1976–2026
Companies that list KZN
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Intraoral Scanner · lntraoral Scanner; Model: Rapid 3, Rapid 5, Infinity 5 | 16 | 2026 |
| PIC dental LLC | United States | Maker | PIC camera | — | — |
| Scan4all SAS | France | Maker | WoW | — | — |
| Mimetrik Solutions Ltd | United Kingdom | Maker | Cubit360 | — | — |
| Lakong Medical Devices Co., Ltd. | China | Foreign exporter | Intraoral Scanners, Rapid 5, Infinity 5 | 2 | 2026 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | Infinity 5 Scanner · Rapid 5 Scanner | 3 | 2007 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Nov 2007 | K072643 | CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US | Olympus Corporation |
| 20 Apr 1977 | K770667 | CHROMASCAN TM | Sterndent Corp. |
Official records: FDA product classification for KZN · 21 CFR 872.3661.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026