Miscellaneous devices · 21 CFR 872 Subpart G
Sterile Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit
FDA device type “Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile”.
- Companies listing it
- 1514 makers
- Brands and models
- 17
- 510(k) clearances
- 50 in five years
- FDA name
- Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
510(k) clearances per year, 1976–2026
Companies that list MCF
15 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Shenzhen Fortunecome Technology Co.,Ltd. | China | Maker | — | — | — |
| Shenzhen Relish Technology Co., Ltd | China | Maker | RLS600 · RLS601,RLS6011,RLS6012,RLS6013,RLS6014,RLS6016,RLS601A,RLS6011A,RLS6012A,RLS6013A,RLS6014A,RLS6016A, | — | — |
| Shenzhen Besman Electronic Technology Co., Ltd | China | Maker | Dentalplaque,PD-01, · Ultraviolet sterilization box, | — | — |
| Qibei Technology Co., Limited | China | Maker | TBX01,TBX02,TBX03,TBX04,TBX05,TBX06,TBX07,TBX08 · Toothbrush sterilizer | — | — |
| Ashtel Studios, Inc. | United States | Maker | Soniclean | — | — |
| Yangzhou Super J Toothbrush Co.,Ltd. | China | Maker | Lindo | — | — |
| Cixi Seago Electronics Co.,ltd | China | Maker | POP DENTAL · SG-507 | — | — |
| Hangzhou Yunchi Technology Co., LTD | China | Maker | Toothbrush sterilizer | — | — |
| Seago Electronics(Thailand)co.,ltd | Thailand | Maker | STERILIZER | — | — |
| Hefei MT Medical Co.,ltd. | China | Maker | Steam Sterilizer, tabletop Autoclaves | — | — |
| BTB Korea Co.,Ltd | South Korea | Maker | SNOR-STOP plus | — | — |
| Guangdong Souncrise Technology Co.,ltd | China | Maker | UV retainer case: SC-UV02, SC-UV03, SC-UV04, SC-UV05 | — | — |
| Uzinmedicare Co., Ltd. | South Korea | Maker | Spectra STERILIZATION | — | — |
| Ningbo Seago Electric Co.,Ltd | China | Maker | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 May 2003 | K023662 | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | Hwadong International Company , Ltd. |
| 10 May 2002 | K021258 | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | Germ Terminator Corporation |
| 6 Jun 2001 | K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC |
| 17 Sep 1990 | K901459 | DS60 TOOTHBRUSH SANITIZER | Associated Mills, Inc. |
| 15 May 1990 | K896481 | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | Purebrush Assoc. |
Official records: FDA product classification for MCF · 21 CFR 872.6855.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026