The following data is part of a premarket notification filed by Metoxit Ag with the FDA for Z-cad Smile.
| Device ID | K170050 |
| 510k Number | K170050 |
| Device Name: | Z-CAD Smile |
| Classification | Powder, Porcelain |
| Applicant | Metoxit AG Emdwiesenstrasse 6 Thayngen, CH Ch-8240 |
| Contact | Dipl.-ing Stefan Leyen |
| Correspondent | Gian-carlo Gullo Metoxit AG Emdwiesenstrasse 6 Thayngen, CH Ch-8240 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMET4119500 | K170050 | 000 |
| EMET4119640 | K170050 | 000 |
| EMET4119650 | K170050 | 000 |
| EMET4119660 | K170050 | 000 |
| EMET4119670 | K170050 | 000 |
| EMET4119680 | K170050 | 000 |
| EMET4119690 | K170050 | 000 |
| EMET4119700 | K170050 | 000 |
| EMET4119710 | K170050 | 000 |
| EMET4119720 | K170050 | 000 |
| EMET4119730 | K170050 | 000 |
| EMET4119740 | K170050 | 000 |
| EMET4119630 | K170050 | 000 |
| EMET4119620 | K170050 | 000 |
| EMET4119510 | K170050 | 000 |
| EMET4119520 | K170050 | 000 |
| EMET4119530 | K170050 | 000 |
| EMET4119540 | K170050 | 000 |
| EMET4119550 | K170050 | 000 |
| EMET4119560 | K170050 | 000 |
| EMET4119570 | K170050 | 000 |
| EMET4119580 | K170050 | 000 |
| EMET4119590 | K170050 | 000 |
| EMET4119600 | K170050 | 000 |
| EMET4119610 | K170050 | 000 |
| EMET4119750 | K170050 | 000 |
| EMET4119760 | K170050 | 000 |
| EMET4119910 | K170050 | 000 |
| EMET4119920 | K170050 | 000 |
| EMET4119930 | K170050 | 000 |
| EMET4119940 | K170050 | 000 |
| EMET4119950 | K170050 | 000 |
| EMET4119960 | K170050 | 000 |
| EMET4119970 | K170050 | 000 |
| EMET4119980 | K170050 | 000 |
| EMET4119990 | K170050 | 000 |
| EMET4120000 | K170050 | 000 |
| EMET4120010 | K170050 | 000 |
| EMET4119900 | K170050 | 000 |
| EMET4119890 | K170050 | 000 |
| EMET4119770 | K170050 | 000 |
| EMET4119780 | K170050 | 000 |
| EMET4119790 | K170050 | 000 |
| EMET4119800 | K170050 | 000 |
| EMET4119810 | K170050 | 000 |
| EMET4119820 | K170050 | 000 |
| EMET4119830 | K170050 | 000 |
| EMET4119840 | K170050 | 000 |
| EMET4119850 | K170050 | 000 |
| EMET4119860 | K170050 | 000 |
| EMET4119880 | K170050 | 000 |
| EMET4120020 | K170050 | 000 |