The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Samsung 10dr Implant System.
| Device ID | K002062 |
| 510k Number | K002062 |
| Device Name: | SAMSUNG 10DR IMPLANT SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey, TX 76227 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-06 |
| Decision Date | 2000-11-09 |