The following data is part of a premarket notification filed by Ultradent Products Inc. / Oratech Llc with the FDA for Ultracem.
| Device ID | K132255 |
| 510k Number | K132255 |
| Device Name: | ULTRACEM |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS INC. / ORATECH LLC 10200 SOUTH 505 WEST South Jordan, UT 84095 |
| Contact | Diane E Roger |
| Correspondent | Diane E Roger ULTRADENT PRODUCTS INC. / ORATECH LLC 10200 SOUTH 505 WEST 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 | 2013-07-19 |
| Decision Date | 2013-10-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ULTRACEM 98316717 not registered Live/Pending |
Kittery Properties, S.A. 2023-12-15 |
![]() ULTRACEM 85404654 4223072 Live/Registered |
Ultradent Products, Inc. 2011-08-23 |
![]() ULTRACEM 76263545 2892269 Dead/Cancelled |
McComas Technologies AG 2001-05-29 |
![]() ULTRACEM 76235483 2860638 Dead/Cancelled |
Universal Chemical Technologies, Inc. 2001-04-05 |
![]() ULTRACEM 75836347 2375509 Live/Registered |
Minova International Limited 1999-10-28 |