CALCIJECT
Liner, Cavity, Calcium Hydroxide
CENTRIX, INC.
The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Calciject.
Pre-market Notification Details
| Device ID | K001050 |
| 510k Number | K001050 |
| Device Name: | CALCIJECT |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | Scott Cohn |
| Correspondent | Scott Cohn 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 | 2000-03-31 |
| Decision Date | 2000-07-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051020822 | K001050 | 000 |
Trademark Results [CALCIJECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALCIJECT 77818759 3777536 Live/Registered |
Centrix, Inc. 2009-09-02 |
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