The following data is part of a premarket notification filed by Ards, Ltd with the FDA for Ards Dental Implants.
| Device ID | K071803 |
| 510k Number | K071803 |
| Device Name: | ARDS DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ARDS, LTD 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub ARDS, LTD 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2008-09-05 |
| Summary: | summary |