The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for D/sense 1-step.
| Device ID | K021146 |
| 510k Number | K021146 |
| Device Name: | D/SENSE 1-STEP |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-07-02 |