The following data is part of a premarket notification filed by Continental Dental Ceramics, Inc. with the FDA for Luxer Shaded Zirconia.
| Device ID | K140070 |
| 510k Number | K140070 |
| Device Name: | LUXER SHADED ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | CONTINENTAL DENTAL CERAMICS, INC. 1872 WESTERN WAY Torrance, CA 90501 |
| Contact | Jerry Doviack |
| Correspondent | Jerry Doviack CONTINENTAL DENTAL CERAMICS, INC. 1872 WESTERN WAY Torrance, CA 90501 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-05-07 |
| Summary: | summary |