The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Prettau, Ice, Z-white Zirconia Blanks.
| Device ID | K183304 |
| 510k Number | K183304 |
| Device Name: | Prettau, ICE, Z-White Zirconia Blanks |
| Classification | Powder, Porcelain |
| 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 | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-28 |
| Decision Date | 2019-04-04 |