The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann 4 Mm Short Implants.
| Device ID | K202942 |
| 510k Number | K202942 |
| Device Name: | Straumann 4 Mm Short Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Contact | Chanrasmey N. White |
| Correspondent | Jennifer M. Jackson Straumann USA, LLS 60 Minuteman Road Andover, MA 01801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031714640 | K202942 | 000 |
| 07630031700841 | K202942 | 000 |
| 07630031700261 | K202942 | 000 |