The following data is part of a premarket notification filed by Chema-scutum, Inc. with the FDA for Cs-11.
| Device ID | K832500 |
| 510k Number | K832500 |
| Device Name: | CS-11 |
| Classification | Coating, Denture Hydrophilic, Resin |
| Applicant | CHEMA-SCUTUM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBE |
| CFR Regulation Number | 872.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-27 |
| Decision Date | 1983-10-27 |