The following data is part of a premarket notification filed by Straumann Usa with the FDA for Iti Synocta Meso Abutments.
| Device ID | K033243 |
| 510k Number | K033243 |
| Device Name: | ITI SYNOCTA MESO ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2003-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031724250 | K033243 | 000 |