Toothette Oral Care
Oral Hygiene Kit, Suction Brush with Antiseptic Oral Rinse and Mouth Moisturizer
16manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (5), Hebei (3), Shanghai (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Ningbo Cooskin Stationery Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 18 |
Showing 12 of 16. All 16 manufacturers in China registered for Patient Personal Hygiene Kit
Record
| Listed by | Sage Products LLC, United States |
|---|---|
| FDA product code | NSB |
| Device type | Patient Personal Hygiene Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2022-07-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100, case of 50 |
| Distribution end date | 2018-03-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6513 | In distribution | |
| 6173 | In distribution | |
| 6550 | In distribution | |
| 6571 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 63 |
| LSL Healthcare | Lsl Industries, Inc. | 11 |
| Q-Care | Sage Products LLC | 10 |
| Ballard™ | SunMed Group Holdings, LLC | 7 |
| Ballard* 24-Hour Oral Care Kit | Avanos Medical, Inc. | 4 |
| Q-Care Rx | Sage Products LLC | 3 |
| Avid Trucustom | Medical Action Industries, Inc. | 2 |
| MediChoice | Owens & Minor Distribution, Inc. | 2 |
| Ballard* Assisted Care 24-Hour Oral Care Kit | Avanos Medical, Inc. | 2 |
| OralKleen | Oralkleen LLC | 2 |
| AVIDTruCustom | Medical Action Industries, Inc. | 1 |
| Sage Self Oral Care | Sage Products LLC | 1 |
Showing 12 of 15. All products under Patient Personal Hygiene Kit
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-05 | Class II | Nonconforming Material/Component | A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes. | 39 Cases (50 kits per case) | 2020-06-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.