The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Calcium Hydroxide Paste.
| Device ID | K943372 |
| 510k Number | K943372 |
| Device Name: | CALCIUM HYDROXIDE PASTE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Contact | L.m. Chatwin |
| Correspondent | L.m. Chatwin ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-09-19 |