The following data is part of a premarket notification filed by Advantage Dental Products, Inc. with the FDA for Temporary Crown Matrix Buttons.
| Device ID | K900389 |
| 510k Number | K900389 |
| Device Name: | TEMPORARY CROWN MATRIX BUTTONS |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | ADVANTAGE DENTAL PRODUCTS, INC. P.O. BOX 214767 Auburn Hills, MI 48321 |
| Contact | K Pelerin |
| Correspondent | K Pelerin ADVANTAGE DENTAL PRODUCTS, INC. P.O. BOX 214767 Auburn Hills, MI 48321 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-07-13 |