The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Elliptic Matrix.
| Device ID | K040539 |
| 510k Number | K040539 |
| Device Name: | ELLIPTIC MATRIX |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | John King |
| Correspondent | John King INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031724700 | K040539 | 000 |
| 07630031724694 | K040539 | 000 |