The following data is part of a premarket notification filed by Whip Mix Corp. with the FDA for Comfortsoft Soft Denture Liner System.
| Device ID | K140146 |
| 510k Number | K140146 |
| Device Name: | COMFORTSOFT SOFT DENTURE LINER SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | WHIP MIX CORP. 361 FARMINGTON AVE Louisville, KY 40217 |
| Contact | John Waters |
| Correspondent | John Waters WHIP MIX CORP. 361 FARMINGTON AVE Louisville, KY 40217 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-04-29 |
| Summary: | summary |