The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permashade Veneer Cement.
| Device ID | K111836 |
| 510k Number | K111836 |
| Device Name: | PERMASHADE VENEER CEMENT |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Corey Jaseph |
| Correspondent | Corey Jaseph 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 | 2011-06-29 |
| Decision Date | 2011-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107619 | K111836 | 000 |
| 00883205027955 | K111836 | 000 |
| 00883205027962 | K111836 | 000 |
| 00883205027979 | K111836 | 000 |
| 00883205027986 | K111836 | 000 |
| 00883205019240 | K111836 | 000 |
| 00883205103000 | K111836 | 000 |
| 00883205106735 | K111836 | 000 |
| 00883205106742 | K111836 | 000 |
| 00883205106759 | K111836 | 000 |
| 00883205106766 | K111836 | 000 |
| 00883205027948 | K111836 | 000 |