The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue.
| Device ID | K181484 |
| 510k Number | K181484 |
| Device Name: | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Zirkonzahn Srl Gewerbegebiet - Zona Industriale An Der Ahr 7 Gais, IT 39030 |
| Contact | Sandra Leitner |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-05 |
| Decision Date | 2018-06-18 |
| Summary: | summary |