The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max Press Multi.
Device ID | K120134 |
510k Number | K120134 |
Device Name: | IPS E.MAX PRESS MULTI |
Classification | Powder, Porcelain |
Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna M Hartnett |
Correspondent | Donna M 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 | 2012-01-17 |
Decision Date | 2012-06-25 |