The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Bone Level Tapered Implant.
| Device ID | K140878 |
| 510k Number | K140878 |
| Device Name: | STRAUMANN BONE LEVEL TAPERED IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-07 |
| Decision Date | 2014-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031707529 | K140878 | 000 |
| 07630031706690 | K140878 | 000 |
| 07630031706683 | K140878 | 000 |
| 07630031706676 | K140878 | 000 |
| 07630031706669 | K140878 | 000 |
| 07630031706652 | K140878 | 000 |
| 07630031706645 | K140878 | 000 |
| 07630031706638 | K140878 | 000 |
| 07630031706621 | K140878 | 000 |
| 07630031706614 | K140878 | 000 |
| 07630031730428 | K140878 | 000 |
| 07630031730411 | K140878 | 000 |
| 07630031730404 | K140878 | 000 |
| 07630031730398 | K140878 | 000 |
| 07630031730381 | K140878 | 000 |
| 07630031730374 | K140878 | 000 |
| 07630031730367 | K140878 | 000 |
| 07630031730350 | K140878 | 000 |
| 07630031706706 | K140878 | 000 |
| 07630031707024 | K140878 | 000 |
| 07630031707031 | K140878 | 000 |
| 07630031707512 | K140878 | 000 |
| 07630031707505 | K140878 | 000 |
| 07630031707499 | K140878 | 000 |
| 07630031707482 | K140878 | 000 |
| 07630031707475 | K140878 | 000 |
| 07630031707468 | K140878 | 000 |
| 07630031707451 | K140878 | 000 |
| 07630031707444 | K140878 | 000 |
| 07630031707437 | K140878 | 000 |
| 07630031707116 | K140878 | 000 |
| 07630031707109 | K140878 | 000 |
| 07630031707093 | K140878 | 000 |
| 07630031707086 | K140878 | 000 |
| 07630031707079 | K140878 | 000 |
| 07630031707062 | K140878 | 000 |
| 07630031707055 | K140878 | 000 |
| 07630031707048 | K140878 | 000 |
| 07630031730343 | K140878 | 000 |