The following data is part of a premarket notification filed by Morningstar Dental Co. with the FDA for Plasticeph.
| Device ID | K810538 |
| 510k Number | K810538 |
| Device Name: | PLASTICEPH |
| Classification | Cephalometer |
| Applicant | MORNINGSTAR DENTAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-26 |
| Decision Date | 1981-04-29 |