The following data is part of a premarket notification filed by C-mix with the FDA for Ceramix Porcelain System.
| Device ID | K000983 |
| 510k Number | K000983 |
| Device Name: | CERAMIX PORCELAIN SYSTEM |
| Classification | Powder, Porcelain |
| Applicant | C-MIX 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward C-MIX 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-08-26 |