The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Team Caries Indicator.
| Device ID | K963927 |
| 510k Number | K963927 |
| Device Name: | TEAM CARIES INDICATOR |
| Classification | Device, Caries Detection |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-10 |
| Decision Date | 1996-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051022369 | K963927 | 000 |
| 00817051022352 | K963927 | 000 |
| 00817051022345 | K963927 | 000 |
| 00817051022338 | K963927 | 000 |
| 00817051021744 | K963927 | 000 |
| 00817051021706 | K963927 | 000 |
| 00817051021690 | K963927 | 000 |