Miscellaneous devices · 21 CFR 872 Subpart G
Dental Hygiene 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
- 3829 makers
- Brands and models
- 49
- 510(k) clearances
- 00 in five years
- FDA name
- Dental Hygiene Kit
Companies that list NXZ
38 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Wuxi EA Medical Instruments Technologies Limited | China | Maker | Patient Kit | 2 | 2023 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| Medline Industries, LP | United States | Maker | DuoCare · Medline · Pint-Sized | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Dental Hygiene Kit | — | — |
| Zhongshan BestClean Technology Co.,Ltd. | China | Maker | Dental hygiene kits · Electrolytic cup for mouthwash | — | — |
| Rabbit Industria e Comercio de Produtos de Higiene Pessoal L | Brazil | Maker | ADL Booster Toothbrush · Doctor Duck Childrens School Toothbrush · Doctor Duck Childrens Toothbrush · Extreme Ice Toothbrush · +2 | — | — |
| Shenzhen Golden Wish Personal Care Co.,Ltd | China | Maker | OCK-05, OCK-06, OCK-07, OCK-08, OCK-09, OCK-10 · Orthodontic Oral Care, Kit, Braces Cleaning Kit, Travel Dental Cleaning Set, OCK-01, OCK-02, OCK-03, OCK-04 | — | — |
| Hager & Werken | Germany | Maker | TONG CLIN GEL · TONG CLIN SET · TONG GEL | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Dental hygiene kit · dental kit | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| Yangzhou Super J Toothbrush Co.,Ltd. | China | Maker | — | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | Dental hygiene kit · pill box · plastic box · Silicone Nipples | — | — |
| Shummi Enterprise Co, Ltd | Taiwan | Maker | Super Dental Kit | — | — |
| Shenzhen Baotonghui Industrial Co.,Ltd | China | Maker | Oral care kit | — | — |
| Chewink Corp. | Taiwan | Maker | Dental oral care hygiene kit | — | — |
| Placecol S.A. | Colombia | Maker | exempt | — | — |
| Jewel Consumer Care Pvt Ltd | India | Maker | GRIN | — | — |
| QUIP NYC Inc. | United States | Maker | quip convenience kit- electric toothbrush and toothpaste | — | — |
| Jiangsu JianYu Health Medical Co., Ltd | China | Maker | Oral Care Kits | — | — |
| HLB Co., LTD. Healthcare | South Korea | Maker | Gum & Tooth care wipes · Oral care tissue | — | — |
| Junhe Industry and Trade Co.,ltd | China | Maker | Travel mouth set | — | — |
| Macrolab Asociados S.A.S. | Colombia | Maker | — | — | — |
| Trademark Medical | United States | Maker | Plak-Vac | — | — |
| Iimed Medical Mexicana S. de R.L. de C.V. | Mexico | Maker | — | — | — |
| AMSINO MEDICAL (SHANGHAI) Co., LTD. | China | Maker | — | — | — |
| Bosma Industries for the Blind, Inc. | United States | Maker | — | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Ming Fai Enterprise (Cambodia) Co.,LTD | Cambodia | Maker | — | — | — |
| SMD Manufacturing LLC | United States | Maker | — | — | — |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | dental hygiene kit | 3 | 2007 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Dentalclean US LLC | United States | Repacker / relabeler | ADL Booster Toothbrush · DC ADVANCED PRO ADULT DENTAL KIT 01X12 · DC ADVANCED PRO ADULT DENTAL KIT 4 PACK 12X04 · Doctor Duck Childrens School Toothbrush · +4 | — | — |
| Summit Packaging Solutions LLC | United States | Repacker / relabeler | Dental Hygiene Kit | — | — |
| Jack And Jill Operations Pty Ltd. | Australia | Foreign exporter | Gum & Tooth Wipes | — | — |
| Hefei Haixi Trading Co., Ltd. | China | Repacker / relabeler | disposable toothbrush · hygiene kits | — | — |
| Hunter Amenities Intl. Ltd | Canada | Foreign exporter | Dental Kit | — | — |
| Teamwork Packaging, Inc. | United States | Contract manufacturer | — | — | — |
Official records: FDA product classification for NXZ · 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