The following data is part of a premarket notification filed by S.i.n.- Sistema De Implante Nacional S.a. with the FDA for S.i.n. Dental Implant System.
| Device ID | K203725 |
| 510k Number | K203725 |
| Device Name: | S.I.N. Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | S.I.N.- Sistema De Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 Sao Paulo, BR 03340-000 |
| Contact | Denise Domiciano |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899995209207 | K203725 | 000 |
| 07899995209115 | K203725 | 000 |
| 07899995209122 | K203725 | 000 |
| 07899995209139 | K203725 | 000 |
| 07899995209146 | K203725 | 000 |
| 07899995209153 | K203725 | 000 |
| 07899995209160 | K203725 | 000 |
| 07899995209177 | K203725 | 000 |
| 07899995209184 | K203725 | 000 |
| 07899995209191 | K203725 | 000 |
| 07899995209108 | K203725 | 000 |