The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Teethmate-a.
| Device ID | K897027 |
| 510k Number | K897027 |
| Device Name: | TEETHMATE-A |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-14 |