The following data is part of a premarket notification filed by Orion Corp. with the FDA for Dentocult Sm-strip Mutans.
| Device ID | K890199 |
| 510k Number | K890199 |
| Device Name: | DENTOCULT SM-STRIP MUTANS |
| Classification | Culture Media, Selective And Differential |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-03-02 |