The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultratemp Firm, Fast And Regular Set.
| Device ID | K080768 |
| 510k Number | K080768 |
| Device Name: | ULTRATEMP FIRM, FAST AND REGULAR SET |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107398 | K080768 | 000 |
| 00883205106872 | K080768 | 000 |
| 00883205106865 | K080768 | 000 |