The following data is part of a premarket notification filed by Straumann Usa (on Behalf Of Institut Straumann Ag) with the FDA for P.004 Abutments.
| Device ID | K071919 |
| 510k Number | K071919 |
| Device Name: | P.004 ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Paige Sweeney |
| Correspondent | Paige Sweeney STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 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 | 2007-07-12 |
| Decision Date | 2007-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031708915 | K071919 | 000 |
| 07630031708908 | K071919 | 000 |
| 07630031708144 | K071919 | 000 |
| 07630031708137 | K071919 | 000 |