The following data is part of a premarket notification filed by Straumann Usa with the FDA for Ortho Implant And Accessories.
| Device ID | K982509 |
| 510k Number | K982509 |
| Device Name: | ORTHO IMPLANT AND ACCESSORIES |
| Classification | Implant, Endosseous, Orthodontic |
| 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 | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-09-30 |
| Summary: | summary |