The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Screw-retained Abutments.
| Device ID | K192401 |
| 510k Number | K192401 |
| Device Name: | Straumann Screw-Retained Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Contact | Jennifer M Jackson |
| Correspondent | Chanrasmey White Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031755827 | K192401 | 000 |
| 07630031745576 | K192401 | 000 |
| 07630031745583 | K192401 | 000 |
| 07630031745590 | K192401 | 000 |
| 07630031745606 | K192401 | 000 |
| 07630031745613 | K192401 | 000 |
| 07630031745620 | K192401 | 000 |
| 07630031745637 | K192401 | 000 |
| 07630031745644 | K192401 | 000 |
| 07630031745569 | K192401 | 000 |
| 07630031745552 | K192401 | 000 |
| 07630031745538 | K192401 | 000 |
| 07630031745439 | K192401 | 000 |
| 07630031745446 | K192401 | 000 |
| 07630031745453 | K192401 | 000 |
| 07630031745477 | K192401 | 000 |
| 07630031745484 | K192401 | 000 |
| 07630031745491 | K192401 | 000 |
| 07630031745514 | K192401 | 000 |
| 07630031745521 | K192401 | 000 |
| 07630031745651 | K192401 | 000 |
| 07630031745668 | K192401 | 000 |
| 07630031745675 | K192401 | 000 |
| 07630031745798 | K192401 | 000 |
| 07630031745804 | K192401 | 000 |
| 07630031745811 | K192401 | 000 |
| 07630031745828 | K192401 | 000 |
| 07630031755810 | K192401 | 000 |
| 07630031746047 | K192401 | 000 |
| 07630031746054 | K192401 | 000 |
| 07630031746061 | K192401 | 000 |
| 07630031745781 | K192401 | 000 |
| 07630031745774 | K192401 | 000 |
| 07630031745767 | K192401 | 000 |
| 07630031745682 | K192401 | 000 |
| 07630031745699 | K192401 | 000 |
| 07630031745705 | K192401 | 000 |
| 07630031745712 | K192401 | 000 |
| 07630031745729 | K192401 | 000 |
| 07630031745736 | K192401 | 000 |
| 07630031745743 | K192401 | 000 |
| 07630031745750 | K192401 | 000 |
| 07630031746078 | K192401 | 000 |