The following data is part of a premarket notification filed by Hukuba Dental Corp. with the FDA for Hubuka Hyg Toothbrush.
| Device ID | K915576 |
| 510k Number | K915576 |
| Device Name: | HUBUKA HYG TOOTHBRUSH |
| Classification | Toothbrush, Ionic, Battery-powered |
| Applicant | HUKUBA DENTAL CORP. 914-1 NAZUKARI Nagareyama City, Chiba, JP 270-0145 |
| Contact | Lee M Evans |
| Correspondent | Lee M Evans HUKUBA DENTAL CORP. 914-1 NAZUKARI Nagareyama City, Chiba, JP 270-0145 |
| Product Code | MMD |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1994-03-04 |