Miscellaneous devices · 21 CFR 872 Subpart G
Oral Irrigation Kit
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
- Companies listing it
- 96 makers
- Brands and models
- 8
- 510(k) clearances
- 00 in five years
- FDA name
- Oral Irrigation Kit
Companies that list OGT
9 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Philips Medical Systems International BV | Netherlands | Maker | Oral Irrigation Kit · ZOOM! Whitening Procedure Kit | 16 | 2010 |
| Candid Care Co. | United States | Maker | FGS-0005 Whitening Kit · ZOOM! Whitening Procedure Kit | — | — |
| Aimi Health Technology (Guangdong) Co., Ltd. | China | Maker | Ear Nose&Throat | — | — |
| Wenzhou Zuoyou Medical Technoloyg Co.,Ltd. | China | Maker | Oral Irrigation | — | — |
| Hangzhou Yunchi Technology Co., LTD | China | Maker | Oral irrigator kits | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Shenzhen Fox Hunting E-commerce Co., Ltd | China | Foreign exporter | Electrified | — | — |
Official records: FDA product classification for OGT · 21 CFR 872.6510.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026