The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Teethmate-f.
| Device ID | K910424 |
| 510k Number | K910424 |
| Device Name: | TEETHMATE-F |
| Classification | Cement, Dental |
| Applicant | KURARAY CO. 200 PARK AVE. New York, NY 10166 |
| Contact | Shuji Kawai |
| Correspondent | Shuji Kawai KURARAY CO. 200 PARK AVE. New York, NY 10166 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-04-03 |