The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Zirkonzahn.implant-planner, Zirkonzahn.implant-planner Practice, Cad/cam Stl Converter, Cad/cam Z-tray.
| Device ID | K203765 |
| 510k Number | K203765 |
| Device Name: | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray |
| Classification | System, Image Processing, Radiological |
| Applicant | Zirkonzahn SRL Via An Der Ahr 7 Gais, IT 39030 |
| Contact | Julian Steger |
| Correspondent | Sandra Leitner Zirkonzahn SRL Via An Der Ahr 7 Gais, IT 39030 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D800SY1620 | K203765 | 000 |
| D800SY1600 | K203765 | 000 |
| D800SY16700 | K203765 | 000 |
| D800SY16600 | K203765 | 000 |