SPEEDCEM
Cement, Dental
IVOCLAR VIVADENT, INC.
The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Speedcem.
Pre-market Notification Details
| Device ID | K091019 |
| 510k Number | K091019 |
| Device Name: | SPEEDCEM |
| Classification | Cement, Dental |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-09 |
| Decision Date | 2009-06-04 |
Trademark Results [SPEEDCEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDCEM 77807121 3783810 Live/Registered |
Ivoclar Vivadent, Inc. 2009-08-18 |
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