The following data is part of a premarket notification filed by Productivity Training Corp. with the FDA for Convertray Custom Impression Tray Material System.
| Device ID | K901782 |
| 510k Number | K901782 |
| Device Name: | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM |
| Classification | Material, Impression Tray, Resin |
| Applicant | PRODUCTIVITY TRAINING CORP. 168 NO. MICHIGAN AVE. SUITE 800 Chicago, IL 60602 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer PRODUCTIVITY TRAINING CORP. 168 NO. MICHIGAN AVE. SUITE 800 Chicago, IL 60602 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-17 |
| Decision Date | 1990-06-29 |