The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Tri-s Bond Plus Single Dose Standard / Value / Introductory Pack.
| Device ID | K111975 |
| 510k Number | K111975 |
| Device Name: | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. OTE CENTER BLD 7F, 1-1-3, OTEMACHI Chiyoda-ku, Tokyo, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY MEDICAL INC. OTE CENTER BLD 7F, 1-1-3, OTEMACHI Chiyoda-ku, Tokyo, 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 | 2011-07-12 |
| Decision Date | 2011-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR002900KA1 | K111975 | 000 |
| EKUR002899KA1 | K111975 | 000 |
| EKUR002898KA1 | K111975 | 000 |