The following data is part of a premarket notification filed by Dentec, Inc. with the FDA for Dentec 4000.
| Device ID | K894930 |
| 510k Number | K894930 |
| Device Name: | DENTEC 4000 |
| Classification | Stimulator, Nerve |
| Applicant | DENTEC, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Rodney Munsey |
| Correspondent | Rodney Munsey DENTEC, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1990-03-27 |