The following data is part of a premarket notification filed by Abcor, Inc. with the FDA for Abcor Caries Detector Monitor.
| Device ID | K791133 |
| 510k Number | K791133 |
| Device Name: | ABCOR CARIES DETECTOR MONITOR |
| Classification | Device, Caries Detection |
| Applicant | ABCOR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-18 |
| Decision Date | 1979-08-28 |