The following data is part of a premarket notification filed by Unix-japan Co., Ltd. with the FDA for Foundation Dental Resin.
| Device ID | K111709 |
| 510k Number | K111709 |
| Device Name: | FOUNDATION DENTAL RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | UNIX-JAPAN CO., LTD. 10920 WILSHIRE BLVD SUITE 150 Los Angeles, CA 90024 |
| Contact | Toshiko Boyd |
| Correspondent | Toshiko Boyd UNIX-JAPAN CO., LTD. 10920 WILSHIRE BLVD SUITE 150 Los Angeles, CA 90024 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FOUNDATION DENTAL RESIN 85356265 not registered Dead/Abandoned |
Unix-Japan Co., Ltd. 2011-06-25 |