The following data is part of a premarket notification filed by Oxy Dental Products, Inc. with the FDA for Oxy Custom Tray Resin.
| Device ID | K801780 |
| 510k Number | K801780 |
| Device Name: | OXY CUSTOM TRAY RESIN |
| Classification | Material, Impression Tray, Resin |
| Applicant | OXY DENTAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-07 |