The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for 4-in-1 Disp. Crown & Bridge Tray.
| Device ID | K780211 |
| 510k Number | K780211 |
| Device Name: | 4-IN-1 DISP. CROWN & BRIDGE TRAY |
| Classification | Tray, Impression, Preformed |
| Applicant | KERR CORPORATION (DANBURY) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHY |
| CFR Regulation Number | 872.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-08 |
| Decision Date | 1978-02-16 |