The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max Press - Abutment Solutions.
Device ID | K120053 |
510k Number | K120053 |
Device Name: | IPS E.MAX PRESS - ABUTMENT SOLUTIONS |
Classification | Abutment, Implant, Dental, Endosseous |
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 | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-06 |
Decision Date | 2012-10-18 |