Miscellaneous devices · 21 CFR 872 Subpart G
Oral Hygiene Rubber Tip
FDA device type “Tip, Rubber, Oral Hygiene”.
- Companies listing it
- 4127 makers
- Brands and models
- 41
- 510(k) clearances
- 30 in five years
- FDA name
- Tip, Rubber, Oral Hygiene
510(k) clearances per year, 1976–2026
Companies that list JEW
41 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Inter-Med, Inc. | United States | Maker | Pocket Probe Assembly | 7 | 2026 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| B&L Biotech Co., Ltd. | South Korea | Maker | JETip | 1 | 2006 |
| HT Co., Ltd. | South Korea | Maker | — | 1 | 2011 |
| Seilglobal CO., Ltd | South Korea | Maker | auto mix tip | 1 | 2015 |
| Allied Hill Enterprises, Ltd. | Hong Kong SAR China | Maker | Oral Care Kits | 1 | 2009 |
| ErgoDenta ApS | Denmark | Maker | Wrench for ErgoTip | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | Oral Tip | — | — |
| Qibei Technology Co., Limited | China | Maker | K01,K02,K03,K05,K06,K07,K08 · Used for oral hygiene or tip | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental tip | — | — |
| CDM Center of Excellence Ltd. | China | Maker | TIP, RUBBER, ORAL HYGIENE | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Maker | Dental Mixing Tips | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| Tess Oral Health | United States | Maker | Proxi-Tip | — | — |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd . | China | Maker | Oral Care Kits | — | — |
| Rosemarie Products Company, LLC | United States | Maker | RM ORAL | — | — |
| Zhejiang Lidesen Medical Instrument Co., Ltd | China | Maker | digital Thermometer covers | — | — |
| Dr. Tung's Inc. | United States | Maker | DR. TUNG'S | — | — |
| Enchant Tek Co. Ltd. | Taiwan | Maker | soft dental picks | — | — |
| YI Shing Co. Ltd. | Hong Kong SAR China | Maker | DENTOOL | — | — |
| Guang Xi FuLaiMing Biopharmaceutics Co., Ltd. | China | Maker | (Oral Dressing):15g, 30g, 60g, 80g, 90g, 100g, 110g, 120g, 130g, 140g per bottle | — | — |
| Suzhou Fumaite Oral Care Products Co. Ltd | China | Maker | Dr Tung's | — | — |
| Jiangsu Zhong Heng Pet Articles Joint-stock CO.,LTD | China | Maker | BLOOM BALL | — | — |
| Jiangxi Partner Home Co., Ltd. | China | Maker | Baby oral hygiene | — | — |
| Ningbo Aolbea Oral Care Products Co., Ltd. | China | Maker | — | — | — |
| DiaDent Group International | South Korea | Foreign exporter | Disposable Tips · Irrigation Tips (End Open Type) · Steri. Irrigation Tips (Side Open Type) | 24 | 2026 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Clinician's Choice® Tubes · Universal Tubes & Plugs | 8 | 2026 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Mixing Tip | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Disposable Tips · Irrigation Tips (End Open Type) · Steri. Irrigation Tips (Side Open Type) | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| battech | United States | Repacker / relabeler | dental mixing tips | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Saliva Ejector | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Oral Tip | — | — |
| Ningbo Top Electric Appliance Co. Ltd. | China | Foreign exporter | — | — | — |
| Summit Packaging Solutions LLC | United States | Repacker / relabeler | Oral Hygiene Rubber Tip | — | — |
| Snowrock USA | United States | Repacker / relabeler | Snow Rock | — | — |
| Robust Ventures Ltd. | United Kingdom | Private-label distributor | Baby Oral Cleaner | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Sep 1986 | K862635 | RABINOWITZ GUM MASSAGER | Arnell, Inc. |
| 11 Dec 1984 | K843406 | CHEW-DENT | Senair-Mot |
| 15 May 1979 | K790588 | ASSAY REAGENTS, LSA 290 | Kallestad Laboratories, Inc. |
Official records: FDA product classification for JEW · 21 CFR 872.6650.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026