The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Ultrafine Tray Adhesive.
| Device ID | K820489 |
| 510k Number | K820489 |
| Device Name: | ULTRAFINE TRAY ADHESIVE |
| 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 | 1982-02-23 |
| Decision Date | 1982-03-19 |