The following data is part of a premarket notification filed by Coors Biomedical Co. with the FDA for Dental Porcelain Powder.
| Device ID | K810822 |
| 510k Number | K810822 |
| Device Name: | DENTAL PORCELAIN POWDER |
| Classification | Powder, Porcelain |
| Applicant | COORS BIOMEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-21 |