The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil.
| Device ID | K131432 |
| 510k Number | K131432 |
| Device Name: | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL |
| 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 |
| Subsequent Product Code | EBF |
| Subsequent Product Code | EMA |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003287KA1 | K131432 | 000 |
| EKUR003286KA1 | K131432 | 000 |
| EKUR003282KA1 | K131432 | 000 |
| EKUR003281KA1 | K131432 | 000 |
| EKUR003275KA1 | K131432 | 000 |
| EKUR003272KA1 | K131432 | 000 |
| EKUR003270KA1 | K131432 | 000 |