The following data is part of a premarket notification filed by Hukuba Dental Corp. with the FDA for Hukuba Hyg Electric Ionic Toothbrush.
| Device ID | K945248 |
| 510k Number | K945248 |
| Device Name: | HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH |
| Classification | Toothbrush, Powered |
| Applicant | HUKUBA DENTAL CORP. 914-1 NAAZUKAR Nagareyama Chiba, JP 270-01 |
| Contact | Lee M Evans |
| Correspondent | Lee M Evans HUKUBA DENTAL CORP. 914-1 NAAZUKAR Nagareyama Chiba, JP 270-01 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-01-26 |