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 |