The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Teethmate F-1.
| Device ID | K012742 |
| 510k Number | K012742 |
| Device Name: | TEETHMATE F-1 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166 |
| Contact | Masaya Sasaki |
| Correspondent | Masaya Sasaki KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE 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 | 2001-08-14 |
| Decision Date | 2001-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR001795KA1 | K012742 | 000 |
| EKUR001790KA1 | K012742 | 000 |
| EKUR001765KA1 | K012742 | 000 |
| EKUR001760KA1 | K012742 | 000 |