The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultratemp Rez Ii.
| Device ID | K211237 |
| 510k Number | K211237 |
| Device Name: | UltraTemp Rez II |
| Classification | Cement, Dental |
| Applicant | Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Shawn L. Quigley |
| Correspondent | Adam Black Ultradent Products, Inc. 505 W Ultradent Drive (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 | 2021-04-26 |
| Decision Date | 2021-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205032911 | K211237 | 000 |
| 00883205030948 | K211237 | 000 |
| 00883205030931 | K211237 | 000 |