PREXION, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007038334 | 3007038334 | PREXION, INC. | 1 | Y | 2020-04-25 | 2077 Gateway Place Suite 120 San Jose CA US 95110 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 82841 | 2021014095 | K190320 | PreXion3D Explorer | OAS | 2019-04-15 |
| 82841 | 1637246128 | K181983 | PreXion 3D Excelsior | OAS | 2018-08-17 |
| 82841 | 1604837229 | K161881 | PreXion3D Excelsior | OAS | 2016-10-03 |
| 82841 | 2027359947 | K122199 | PREXION3D ECLIPSE | OAS | 2013-04-18 |
| 82841 | 1275779783 | K120948 | PREXION 3D | OAS | 2012-12-21 |
| 82841 | 1508277435 | K063622 | FINECUBE DENTAL CT | OAS | 2007-02-08 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OAS | 6 | 2019-04-15 |