The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Sofreliner Tough S.
| Device ID | K112445 |
| 510k Number | K112445 |
| Device Name: | SOFRELINER TOUGH S |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-10-28 |
| Summary: | summary |