The following data is part of a premarket notification filed by Straumann Usa with the FDA for Synocta Angled Abutments.
| Device ID | K994119 |
| 510k Number | K994119 |
| Device Name: | SYNOCTA ANGLED ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725332 | K994119 | 000 |
| 07630031725325 | K994119 | 000 |
| 07630031725318 | K994119 | 000 |
| 07630031725301 | K994119 | 000 |
| 07630031725295 | K994119 | 000 |
| 07630031725288 | K994119 | 000 |
| 07630031725271 | K994119 | 000 |
| 07630031725264 | K994119 | 000 |