The following data is part of a premarket notification filed by Straumann Usa with the FDA for Dental Implant Coping (prosthetic Accessories To The Iti Dental Implant System).
| Device ID | K032498 |
| 510k Number | K032498 |
| Device Name: | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-13 |
| Decision Date | 2003-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725004 | K032498 | 000 |
| 07630031724991 | K032498 | 000 |