The following data is part of a premarket notification filed by Jiangsu Trausim Medical Instrument with the FDA for Trausim Dental Implant System.
| Device ID | K140202 |
| 510k Number | K140202 |
| Device Name: | TRAUSIM DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JIANGSU TRAUSIM MEDICAL INSTRUMENT WEST RENMIN RD., NIUTANG TOWN, WUJIN DIST. Changzhou City, Jaingsu Provicne, CN 213163 |
| Contact | Luo Zhicong |
| Correspondent | Luo Zhicong JIANGSU TRAUSIM MEDICAL INSTRUMENT WEST RENMIN RD., NIUTANG TOWN, WUJIN DIST. Changzhou City, Jaingsu Provicne, CN 213163 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-12-12 |