The following data is part of a premarket notification filed by Solar Dental Co., Inc. with the FDA for Solarcryl Custom Tray Material.
| Device ID | K831293 |
| 510k Number | K831293 |
| Device Name: | SOLARCRYL CUSTOM TRAY MATERIAL |
| Classification | Material, Impression Tray, Resin |
| Applicant | SOLAR DENTAL CO., 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 | 1983-04-20 |
| Decision Date | 1983-07-26 |