The following data is part of a premarket notification filed by Glidewell Laboratories with the FDA for Prismatik Ceramic.
| Device ID | K050144 |
| 510k Number | K050144 |
| Device Name: | PRISMATIK CERAMIC |
| Classification | Powder, Porcelain |
| Applicant | GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Contact | Keith D Allred |
| Correspondent | Keith D Allred GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-03-03 |
| Summary: | summary |