The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Clearfil Tri-s Bond Plus.
| Device ID | K111980 |
| 510k Number | K111980 |
| Device Name: | CLEARFIL TRI-S BOND PLUS |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY AMERICA, INC. 600 LEXINGTON AVE. 26TH FLOOR New York, NY 10022 |
| Contact | Kiyoyuki Arikawa |
| Correspondent | Kiyoyuki Arikawa KURARAY AMERICA, INC. 600 LEXINGTON AVE. 26TH FLOOR New York, NY 10022 |
| 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 |
|---|---|---|
| EKUR002893KA1 | K111980 | 000 |
| EKUR002892KA1 | K111980 | 000 |
| EKUR002891KA1 | K111980 | 000 |
| EKUR002890KA1 | K111980 | 000 |