The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Prefgel.
| Device ID | K162311 |
| 510k Number | K162311 |
| Device Name: | Straumann PrefGel |
| Classification | Cleanser, Root Canal |
| Applicant | INSTITUT STRAUMANN AG PETER MERIAN WEG 12 Basel, CH Ch-4002 |
| Contact | Christopher Klaczyk |
| Correspondent | Jennifer M. Jackson STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-18 |
| Decision Date | 2017-03-07 |
| Summary: | summary |