The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips 99 One And Ips 99 Ceram.
| Device ID | K121359 |
| 510k Number | K121359 |
| Device Name: | IPS 99 ONE AND IPS 99 CERAM |
| Classification | Powder, Porcelain |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-07-27 |