The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Polysulfide Custom Tray Material.
| Device ID | K841490 |
| 510k Number | K841490 |
| Device Name: | POLYSULFIDE CUSTOM TRAY MATERIAL |
| Classification | Material, Impression |
| Applicant | BUFFALO DENTAL MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-10 |
| Decision Date | 1984-06-27 |