The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips Style Ceram, Ips Style Ceram One, Ips Style Press.
| Device ID | K152103 |
| 510k Number | K152103 |
| Device Name: | IPS Style Ceram, IPS Style Ceram One, IPS Style Press |
| Classification | Powder, Porcelain |
| Applicant | Ivoclar Vivadent AG Bendererstrasse 2 Schaan, LI 9494 |
| Contact | Sandra Cakebread |
| Correspondent | Donna Hartnett Ivoclar Vivadent, Inc. 175 Pineview Drive 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 | 2015-07-29 |
| Decision Date | 2016-05-20 |
| Summary: | summary |