The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max Cad Abutment Solutions.
| Device ID | K132209 |
| 510k Number | K132209 |
| Device Name: | IPS E.MAX CAD ABUTMENT SOLUTIONS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Hartnett |
| Correspondent | Donna Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. 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 | 2013-07-16 |
| Decision Date | 2013-10-31 |
| Summary: | summary |