The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Saliva-stim.
| Device ID | K914892 |
| 510k Number | K914892 |
| Device Name: | SALIVA-STIM |
| Classification | Wax, Dental, Intraoral |
| Applicant | ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-09-02 |