The following data is part of a premarket notification filed by Sgs International Ltd with the FDA for Sgs Dental Implant.
| Device ID | K133362 |
| 510k Number | K133362 |
| Device Name: | SGS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SGS INTERNATIONAL LTD 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Contact | Daniela Levy |
| Correspondent | Daniela Levy SGS INTERNATIONAL LTD 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-01 |
| Decision Date | 2014-11-21 |
| Summary: | summary |