The following data is part of a premarket notification filed by Dentis Co. Ltd. with the FDA for Dentis Dental Implant System.
| Device ID | K073486 |
| 510k Number | K073486 |
| Device Name: | DENTIS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTIS CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Contact | Chang Dae Kyu |
| Correspondent | Chang Dae Kyu DENTIS CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880616910030 | K073486 | 000 |
| 08806169100801 | K073486 | 000 |