The following data is part of a premarket notification filed by Straumann Usa with the FDA for Synocta Prosthetics.
| Device ID | K990342 |
| 510k Number | K990342 |
| Device Name: | SYNOCTA PROSTHETICS |
| 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 | 1999-02-04 |
| Decision Date | 1999-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031726018 | K990342 | 000 |
| 07630031725387 | K990342 | 000 |
| 07630031725370 | K990342 | 000 |
| 07630031725349 | K990342 | 000 |
| 07630031725189 | K990342 | 000 |
| 07630031723734 | K990342 | 000 |
| 07630031723598 | K990342 | 000 |
| 07630031717252 | K990342 | 000 |
| 07630031701190 | K990342 | 000 |
| 07630031739254 | K990342 | 000 |
| 07630031725479 | K990342 | 000 |
| 07630031725417 | K990342 | 000 |
| 07630031725431 | K990342 | 000 |
| 07630031726001 | K990342 | 000 |
| 07630031725998 | K990342 | 000 |
| 07630031725981 | K990342 | 000 |
| 07630031725646 | K990342 | 000 |
| 07630031725622 | K990342 | 000 |
| 07630031725615 | K990342 | 000 |
| 07630031725608 | K990342 | 000 |
| 07630031725592 | K990342 | 000 |
| 07630031725523 | K990342 | 000 |
| 07630031725516 | K990342 | 000 |
| 07630031725462 | K990342 | 000 |