The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Eris Layering Materials.
| Device ID | K012174 |
| 510k Number | K012174 |
| Device Name: | ERIS LAYERING MATERIALS |
| Classification | Powder, Porcelain |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR NORTH AMERICA, 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 | 2001-07-12 |
| Decision Date | 2001-08-27 |