The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for N!ce Glass Ceramic Blocks For Amann Girrbach.
| Device ID | K170420 |
| 510k Number | K170420 |
| Device Name: | N!ce Glass Ceramic Blocks For Amann Girrbach |
| Classification | Powder, Porcelain |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH |
| Contact | Christopher Klaczyk |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2017-03-02 |
| Summary: | summary |