The following data is part of a premarket notification filed by Sagemax Bioceramics, Inc. with the FDA for Sagemax Z-blank.
| Device ID | K062695 |
| 510k Number | K062695 |
| Device Name: | SAGEMAX Z-BLANK |
| Classification | Powder, Porcelain |
| Applicant | SAGEMAX BIOCERAMICS, INC. 11061 NE 2ND STREET SUITE 168 Bellevue, WA 98004 |
| Contact | Larry Dang |
| Correspondent | Larry Dang SAGEMAX BIOCERAMICS, INC. 11061 NE 2ND STREET SUITE 168 Bellevue, WA 98004 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-10-20 |
| Summary: | summary |