The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Bonefit R Screw Implants.
| Device ID | K894595 |
| 510k Number | K894595 |
| Device Name: | BONEFIT R SCREW IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG CH-4437 Walenburg, Switzerland, CH |
| Contact | Walter Widmer |
| Correspondent | Walter Widmer INSTITUT STRAUMANN AG CH-4437 Walenburg, Switzerland, CH |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-02-13 |