APEXCAL
Liner, Cavity, Calcium Hydroxide
IVOCLAR VIVADENT, INC.
The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Apexcal.
Pre-market Notification Details
| Device ID | K060365 |
| 510k Number | K060365 |
| Device Name: | APEXCAL |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-04-17 |
Trademark Results [APEXCAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APEXCAL 79008105 3029513 Dead/Cancelled |
Ivoclar Vivadent AG 2004-07-05 |
 APEXCAL 78409508 3213886 Live/Registered |
Ivoclar Vivadent, Inc. 2004-04-28 |
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