The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Bone Level Nc Angled Screw Retained Abutments.
| Device ID | K141871 |
| 510k Number | K141871 |
| Device Name: | Straumann Bone Level NC Angled Screw Retained Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031708434 | K141871 | 000 |
| 07630031708304 | K141871 | 000 |
| 07630031708311 | K141871 | 000 |
| 07630031708328 | K141871 | 000 |
| 07630031708335 | K141871 | 000 |
| 07630031708342 | K141871 | 000 |
| 07630031708359 | K141871 | 000 |
| 07630031708366 | K141871 | 000 |
| 07630031708410 | K141871 | 000 |
| 07630031708427 | K141871 | 000 |
| 07630031708441 | K141871 | 000 |
| 07630031708458 | K141871 | 000 |
| 07630031708465 | K141871 | 000 |
| 07630031708472 | K141871 | 000 |
| 07630031708489 | K141871 | 000 |
| 07630031708298 | K141871 | 000 |