The following data is part of a premarket notification filed by Alpha-dent with the FDA for Alpha-dent Core Buildup Paste.
| Device ID | K932827 |
| 510k Number | K932827 |
| Device Name: | ALPHA-DENT CORE BUILDUP PASTE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Contact | George Nicolae |
| Correspondent | George Nicolae ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-09-23 |