The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Ips E.max Cad/ips E.max Zircad.
| Device ID | K051705 |
| 510k Number | K051705 |
| Device Name: | IPS E.MAX CAD/IPS E.MAX ZIRCAD |
| Classification | Powder, Porcelain |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 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 | 2005-06-24 |
| Decision Date | 2005-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024014497 | K051705 | 000 |
| 00889024014428 | K051705 | 000 |
| 00889024014350 | K051705 | 000 |