The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Ceramic Primer Plus, Clearfil Ceramic Primer Plus (trial).
| Device ID | K150703 |
| 510k Number | K150703 |
| Device Name: | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG. 7F, 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003638KA1 | K150703 | 000 |
| EKUR003637KA1 | K150703 | 000 |