The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Ips E.max Crown.
| Device ID | K100512 |
| 510k Number | K100512 |
| Device Name: | NOBELPROCERA IPS E.MAX CROWN |
| Classification | Powder, Porcelain |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-08-20 |
| Summary: | summary |