The following data is part of a premarket notification filed by Straumann Institute, Ltd. with the FDA for Bonefit Implant System Accessories & Instruments.
| Device ID | K894844 |
| 510k Number | K894844 |
| Device Name: | BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN INSTITUTE, LTD. 50 LONGWOOD AVENUE, APT. 412 Brookline, MA 02146 |
| Contact | Hans-peter Weber |
| Correspondent | Hans-peter Weber STRAUMANN INSTITUTE, LTD. 50 LONGWOOD AVENUE, APT. 412 Brookline, MA 02146 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1990-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031724953 | K894844 | 000 |
| 07630031717863 | K894844 | 000 |
| 07630031717870 | K894844 | 000 |
| 07630031717887 | K894844 | 000 |
| 07630031722379 | K894844 | 000 |
| 07630031723550 | K894844 | 000 |
| 07630031723567 | K894844 | 000 |
| 07630031723642 | K894844 | 000 |
| 07630031723659 | K894844 | 000 |
| 07630031717856 | K894844 | 000 |
| 07630031717849 | K894844 | 000 |
| 07630031776068 | K894844 | 000 |
| 07630031728890 | K894844 | 000 |
| 07630031717382 | K894844 | 000 |
| 07630031717795 | K894844 | 000 |
| 07630031717801 | K894844 | 000 |
| 07630031717818 | K894844 | 000 |
| 07630031717825 | K894844 | 000 |
| 07630031717832 | K894844 | 000 |
| 07630031724199 | K894844 | 000 |
| 07630031724267 | K894844 | 000 |
| 07630031724595 | K894844 | 000 |
| 07630031724601 | K894844 | 000 |
| 07630031724786 | K894844 | 000 |
| 07630031724816 | K894844 | 000 |
| 07630031724915 | K894844 | 000 |
| 07630031724922 | K894844 | 000 |
| 07630031724939 | K894844 | 000 |
| 07630031724946 | K894844 | 000 |
| 07630031724472 | K894844 | 000 |
| 07630031724441 | K894844 | 000 |
| 07630031724274 | K894844 | 000 |
| 07630031724298 | K894844 | 000 |
| 07630031724304 | K894844 | 000 |
| 07630031724311 | K894844 | 000 |
| 07630031724328 | K894844 | 000 |
| 07630031724335 | K894844 | 000 |
| 07630031724397 | K894844 | 000 |
| 07630031724434 | K894844 | 000 |
| 07630031776051 | K894844 | 000 |