The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Synocta Angled Abutments For The Iti Wide Neck Implant.
| Device ID | K013891 |
| 510k Number | K013891 |
| Device Name: | SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725257 | K013891 | 000 |
| 07630031725240 | K013891 | 000 |