The following data is part of a premarket notification filed by Southern Implants, Inc. with the FDA for Endosseous Dental Implant System.
| Device ID | K070841 |
| 510k Number | K070841 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030 |
| Contact | Greta M Hols |
| Correspondent | Greta M Hols SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544010364 | K070841 | 000 |
| D768AMCZ30 | K070841 | 000 |
| D768AMCZ20 | K070841 | 000 |
| D768AMCZ10 | K070841 | 000 |
| D768IBT12D850 | K070841 | 000 |
| D768IBT12D180 | K070841 | 000 |
| D768IBT12D150 | K070841 | 000 |
| D768IBT12D130 | K070841 | 000 |
| D768IBT12D1150 | K070841 | 000 |
| D768IBT12D100 | K070841 | 000 |
| 06009544022756 | K070841 | 000 |
| 06009544008613 | K070841 | 000 |
| 06009544008620 | K070841 | 000 |
| 06009544008606 | K070841 | 000 |
| 06009544008590 | K070841 | 000 |
| 06009544008446 | K070841 | 000 |
| 06009544008439 | K070841 | 000 |
| 06009544008422 | K070841 | 000 |
| D768AMCZ40 | K070841 | 000 |
| D768AMCZ50 | K070841 | 000 |
| D768GSQZ20 | K070841 | 000 |
| 06009544010357 | K070841 | 000 |
| 06009544010340 | K070841 | 000 |
| 06009544010333 | K070841 | 000 |
| 06009544010326 | K070841 | 000 |
| 06009544010319 | K070841 | 000 |
| 06009544010302 | K070841 | 000 |
| 06009544010296 | K070841 | 000 |
| 06009544010289 | K070841 | 000 |
| 06009544010272 | K070841 | 000 |
| 06009544010265 | K070841 | 000 |
| 06009544010258 | K070841 | 000 |
| 06009544010241 | K070841 | 000 |
| 06009544000815 | K070841 | 000 |
| D768TSHZ30 | K070841 | 000 |
| D768TSHZ20 | K070841 | 000 |
| D768GSUZ30 | K070841 | 000 |
| D768GSQZ30 | K070841 | 000 |
| 06009544008415 | K070841 | 000 |