CLEARFIL DC CORE PLUS
Material, Tooth Shade, Resin
KURARAY AMERICA, INC.
The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Clearfil Dc Core Plus.
Pre-market Notification Details
| Device ID | K111982 |
| 510k Number | K111982 |
| Device Name: | CLEARFIL DC CORE PLUS |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2011-11-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR002943KA1 | K111982 | 000 |
| EKUR002942KA1 | K111982 | 000 |
| EKUR001031KA1 | K111982 | 000 |
| EKUR001030KA1 | K111982 | 000 |
| EKUR001029KA1 | K111982 | 000 |
Trademark Results [CLEARFIL DC CORE PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL DC CORE PLUS 85179771 4127620 Live/Registered |
Kuraray Co., Ltd. 2010-11-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.