The following data is part of a premarket notification filed by Dental Technologies, Inc. with the FDA for Alpha-pro White Varnish.
| Device ID | K124025 |
| 510k Number | K124025 |
| Device Name: | ALPHA-PRO WHITE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | DENTAL TECHNOLOGIES, INC. 6901 NORTH HAMLIN AVE. Lincolnwood, IL 60712 |
| Contact | Paula Erickson |
| Correspondent | Paula Erickson DENTAL TECHNOLOGIES, INC. 6901 NORTH HAMLIN AVE. Lincolnwood, IL 60712 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813VN205S0 | K124025 | 000 |
| D813VN200ST1 | K124025 | 000 |