The following data is part of a premarket notification filed by Danville Engineering, Inc. with the FDA for Caries Finder.
| Device ID | K955445 |
| 510k Number | K955445 |
| Device Name: | CARIES FINDER |
| Classification | Device, Caries Detection |
| Applicant | DANVILLE ENGINEERING, INC. 1901 SAN RAMON VALLEY BLVD. San Ramon, CA 94583 |
| Contact | Craig R Bruns |
| Correspondent | Craig R Bruns DANVILLE ENGINEERING, INC. 1901 SAN RAMON VALLEY BLVD. San Ramon, CA 94583 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1996-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818207020106 | K955445 | 000 |
| 10818207020052 | K955445 | 000 |