K203765 is an FDA 510(k) clearance for the ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on July 20, 2021, 209 days after receiving the submission on December 23, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K203765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | July 20, 2021 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |