The following data is part of a premarket notification filed by Straumann Usa with the FDA for Narrow Connection Straumann Anatomic Ips E.max Abutments.
| Device ID | K110580 |
| 510k Number | K110580 |
| Device Name: | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 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 | 2011-03-01 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031708588 | K110580 | 000 |
| 07630031708571 | K110580 | 000 |
| 07630031708564 | K110580 | 000 |
| 07630031708557 | K110580 | 000 |
| 07630031708540 | K110580 | 000 |
| 07630031708533 | K110580 | 000 |
| 07630031708526 | K110580 | 000 |
| 07630031708519 | K110580 | 000 |