The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Implantium Prosthetics.
| Device ID | K070228 |
| 510k Number | K070228 |
| Device Name: | IMPLANTIUM PROSTHETICS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DENTIUM CO., LTD. 5536 TROWBRIDGE DR Atlanta, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria DENTIUM CO., LTD. 5536 TROWBRIDGE DR Atlanta, GA 30338 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-11-20 |
| Summary: | summary |