The following data is part of a premarket notification filed by Kuraray Company, Ltd. with the FDA for Teethmate F-1.
| Device ID | K965091 |
| 510k Number | K965091 |
| Device Name: | TEETHMATE F-1 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Koji Fujita |
| Correspondent | Koji Fujita KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-03-27 |
| Summary: | summary |