The following data is part of a premarket notification filed by Kuraray Noritake Dental, Inc. with the FDA for Clearfil Universal Bond Quick Bottle Standard Kit, Clearfil Universal Bond Quick Bottle Refill, Clearfil Universal Bond Quick Bottle Value Pack.
| Device ID | K161042 |
| 510k Number | K161042 |
| Device Name: | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value Pack |
| 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 | 2016-04-13 |
| Decision Date | 2016-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003579KA1 | K161042 | 000 |
| EKUR003578KA1 | K161042 | 000 |
| EKUR003577KA1 | K161042 | 000 |
| EKUR003575KA1 | K161042 | 000 |
| EKUR003574KA1 | K161042 | 000 |
| EKUR003572KA1 | K161042 | 000 |
| EKUR003571KA1 | K161042 | 000 |
| EKUR003569AL1 | K161042 | 000 |