The following data is part of a premarket notification filed by Sterndent Corp. with the FDA for Chromascan Tm.
| Device ID | K770667 |
| 510k Number | K770667 |
| Device Name: | CHROMASCAN TM |
| Classification | Scanner, Color |
| Applicant | STERNDENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZN |
| CFR Regulation Number | 872.3661 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-08 |
| Decision Date | 1977-04-20 |