The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultratemp Temporary Polycarboxylate Cement.
| Device ID | K994261 |
| 510k Number | K994261 |
| Device Name: | ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Scott E Moore |
| Correspondent | Scott E Moore ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-02-02 |