The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Caries Detector.
| Device ID | K951813 |
| 510k Number | K951813 |
| Device Name: | CARIES DETECTOR |
| Classification | Device, Caries Detection |
| Applicant | KURARAY CO. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn KURARAY CO. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-18 |
| Decision Date | 1995-07-11 |