The following data is part of a premarket notification filed by Yeti Dentalprodukte Gmbh with the FDA for K2 Zirkon Blank White Classic; K2 Zirkon Blank Translucent; K2 Blanks Extreme Translucent.
| Device ID | K173971 |
| 510k Number | K173971 |
| Device Name: | K2 Zirkon Blank White Classic; K2 Zirkon Blank Translucent; K2 Blanks Extreme Translucent |
| Classification | Powder, Porcelain |
| Applicant | Yeti Dentalprodukte Gmbh Industriestrasse 3a Engen, DE 78234 |
| Contact | Thomas Biskupski |
| Correspondent | Thomas Biskupski Yeti Dentalprodukte Gmbh Industriestrasse 3a Engen, DE 78234 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-11-15 |
| Summary: | summary |