The following data is part of a premarket notification filed by Dentatus Usa, Ltd. with the FDA for Dentatus Mti Modular Transitional Implants And Prosthetic System.
| Device ID | K980620 |
| 510k Number | K980620 |
| Device Name: | DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
| Contact | Stephen B Rubinsky |
| Correspondent | Stephen B Rubinsky DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-05-15 |
| Summary: | summary |