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 |