The following data is part of a premarket notification filed by Dental Technologies, Inc. with the FDA for Alpha-core Dc.
| Device ID | K070191 |
| 510k Number | K070191 |
| Device Name: | ALPHA-CORE DC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTAL TECHNOLOGIES, INC. 6901 NORTH HAMLIN AVE. Lincolnwood, IL 60712 |
| Contact | Janine Rauhut |
| Correspondent | Janine Rauhut DENTAL TECHNOLOGIES, INC. 6901 NORTH HAMLIN AVE. Lincolnwood, IL 60712 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-01-22 |
| Decision Date | 2007-03-07 |