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 |