The following data is part of a premarket notification filed by Mycone Dental Supply Co., Inc. with the FDA for Mizzy Express.
| Device ID | K093380 |
| 510k Number | K093380 |
| Device Name: | MIZZY EXPRESS |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Contact | Nick Palmer |
| Correspondent | Nick Palmer MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-03-05 |