The following data is part of a premarket notification filed by Ivoclar Vivadent, Agin with the FDA for Ips E. Max Press Abutment Solutions For Nobel Biocare.
Device ID | K124008 |
510k Number | K124008 |
Device Name: | IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | IVOCLAR VIVADENT, AGIN 175 PINEVIEW DRIVE Amherst, NY 14228 |
Contact | Donna Marie Hartnett |
Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, AGIN 175 PINEVIEW DRIVE Amherst, NY 14228 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-27 |
Decision Date | 2013-03-29 |
Summary: | summary |