The following data is part of a premarket notification filed by Jfc International, Inc. with the FDA for Zact Dental Arch Toothbrusch.
| Device ID | K833815 |
| 510k Number | K833815 |
| Device Name: | ZACT DENTAL ARCH TOOTHBRUSCH |
| Classification | Toothbrush, Manual |
| Applicant | JFC INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-02 |
| Decision Date | 1984-02-10 |