The following data is part of a premarket notification filed by Kerox Ltd with the FDA for Zirconia Blanks (zircostar).
| Device ID | K120852 |
| 510k Number | K120852 |
| Device Name: | ZIRCONIA BLANKS (ZIRCOSTAR) |
| Classification | Powder, Porcelain |
| Applicant | KEROX LTD 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Sangram Yadav |
| Correspondent | Sangram Yadav KEROX LTD 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-21 |
| Decision Date | 2012-06-06 |
| Summary: | summary |