The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Light Cure Dentin And Liner Base Product Line.
| Device ID | K921408 |
| 510k Number | K921408 |
| Device Name: | LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Linda Chatwin |
| Correspondent | Linda Chatwin ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-11-24 |