| Approved | FDA |
|---|---|
| FDA for Curing Light | 510(K) Number: K192233 |
| FDA for Handpiece | 510(K) Number: K181691 |
| Brand | Unbranded |
| Product | Acquisition Scanner |
| Intended Use/Discipline | Dentistry |
| Country of Origin | China |
Check the listing for details. Dental Intra-oral 3D Scanner OPERA SYSTEM Windows 10/11 64bit With Software. Condition: New, Made in China. Listed at 2799.00 USD. 3DS V5 Dental 3D Intraoral Scanner. The next-generation digital impression solution designed for modern dental clinics. One-piece seamless body for easy cleaning & disinfection. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.
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