The following data is part of a premarket notification filed by Straumann Usa with the FDA for Angled Abutment.
| Device ID | K962647 |
| 510k Number | K962647 |
| Device Name: | ANGLED ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Contact | Amy M Gardner |
| Correspondent | Amy M Gardner STRAUMANN USA ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-10-07 |
| Summary: | summary |