Plak-Vac
Plak-Vac custom kit
12manufacturers in China registered for this device type
134catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Zhongshan BestClean Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
| Shenzhen Baotonghui Industrial Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 11 |
| Shumei Industrial (Hebei) Co., Ltd. | Cangzhou | Hebei | Contract manufacturer | 10 |
| Shenzhen Golden Wish Personal Care Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Junhe Industry AND Trade Co., Ltd. | Yangjiang | Guangdong | Manufacturer | 8 |
| Yangzhou Super J Toothbrush Co., Ltd. | Guangling District | Jiangsu | Manufacturer | 8 |
| Wuxi EA Medical Instruments Technologies Limited | Wuxi | Jiangsu | Repacker / relabeller | 6 |
Record
| Listed by | Trademark Medical, L.L.C. |
|---|---|
| FDA product code | NXZ |
| Device type | Dental Hygiene Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Premarket notification | Exempt |
| Record published | 2021-11-16 |
| Record revised | 2019-07-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 7 to 37 °C; Storage environment temperature 7 to 37 °C |
| Packaging | Case of 24, case of 100, case of 12, cases of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3060 | In distribution | |
| 3107 | In distribution | |
| 2644 | In distribution | |
| 3106 | In distribution | |
| 3035 | In distribution | |
| 3067 | In distribution | |
| 2414 | In distribution | |
| 3065 | In distribution | |
| 2633 | In distribution | |
| 3063 | In distribution | |
| 2413 | In distribution | |
| 3096 | In distribution | |
| 2484 | In distribution | |
| 2587 | In distribution | |
| 3085 | In distribution | |
| 3026 | In distribution | |
| 3070 | In distribution | |
| 3015 | In distribution | |
| 3042 | In distribution | |
| 2470 | In distribution | |
| 2551 | In distribution | |
| 3105 | In distribution | |
| 2592 | In distribution | |
| 3032 | In distribution | |
| 2523 | In distribution | |
| 2604 | In distribution | |
| 2487 | In distribution | |
| 3053 | In distribution | |
| 3104 | In distribution | |
| 2453 | In distribution | |
| 2436 | In distribution | |
| 3064 | In distribution | |
| 3046 | In distribution | |
| 3062 | In distribution | |
| 3023 | In distribution | |
| 3074 | In distribution | |
| 2628 | In distribution | |
| 2647 | In distribution | |
| 3088 | In distribution | |
| 2552 | In distribution | |
| 2646 | In distribution | |
| 3075 | In distribution | |
| 3041 | In distribution | |
| 3073 | In distribution | |
| 3043 | In distribution | |
| 2629 | In distribution | |
| 2640 | In distribution | |
| 2632 | In distribution | |
| 2524 | In distribution | |
| 3103 | In distribution | |
| 2383-01 | In distribution | |
| 2643 | In distribution | |
| 2394 | In distribution | |
| 2411 | In distribution | |
| 2608 | In distribution | |
| 3003 | In distribution | |
| 2481 | In distribution | |
| 3009 | In distribution | |
| 3097 | In distribution | |
| 2540 | In distribution | |
| 2627 | In distribution | |
| 3061 | In distribution | |
| 3059 | In distribution | |
| 2541 | In distribution | |
| 2344 | In distribution | |
| 3077 | In distribution | |
| 3094 | In distribution | |
| 2562 | In distribution | |
| 2569 | In distribution | |
| 2412 | In distribution | |
| 3012 | In distribution | |
| 2575 | In distribution | |
| 2568 | In distribution | |
| 2624 | In distribution | |
| 2442 | In distribution | |
| 3090 | In distribution | |
| 2602 | In distribution | |
| 2529 | In distribution | |
| 3115 | In distribution | |
| 2486 | In distribution | |
| 2415 | In distribution | |
| 3095 | In distribution | |
| 2503 | In distribution | |
| 2593 | In distribution | |
| 3019 | In distribution | |
| 3045 | In distribution | |
| 3098 | In distribution | |
| 3028 | In distribution | |
| 3038 | In distribution | |
| 3091 | In distribution | |
| 3055 | In distribution | |
| 3092 | In distribution | |
| 3084 | In distribution | |
| 2337 | In distribution | |
| 2634 | In distribution | |
| 3102 | In distribution | |
| 3014 | In distribution | |
| 3072 | In distribution | |
| 3093 | In distribution | |
| 3068 | In distribution | |
| 2454 | In distribution | |
| 2589 | In distribution | |
| 2594 | In distribution | |
| 3056 | In distribution | |
| 2465 | In distribution | |
| 2626 | In distribution | |
| 2601 | In distribution | |
| 2561 | In distribution | |
| 3083 | In distribution | |
| 3037 | In distribution | |
| 3040 | In distribution | |
| 3024 | In distribution | |
| 2596 | In distribution | |
| 3044 | In distribution | |
| 2641 | In distribution | |
| 3087 | In distribution | |
| 3039 | In distribution | |
| 3054 | In distribution | |
| 2492 | In distribution | |
| 3002 | In distribution | |
| 2579 | In distribution | |
| 2507 | In distribution | |
| 2392 | In distribution | |
| 2554 | In distribution | |
| 2508 | In distribution | |
| 3108 | In distribution | |
| 3086 | In distribution | |
| 2425 | In distribution | |
| 2550 | In distribution | |
| 2445 | In distribution | |
| 2567 | In distribution | |
| 2638 | In distribution | |
| 2485 | In distribution | |
| 2405 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Centurion | Centurion Medical Products Corporation | 15 |
| Bosma Enterprises | Bosma Enterprises | 5 |
| Stradis | Stradis Healthcare | 5 |
| Medline Industries | Medline Industries, Inc. | 2 |
| Stradis Healthcare | Stradis Healthcare | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Oral Relief Kitz | Orthonu, LLC | 1 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 1 |
| Angel Aligner | Wuxi EA Medical Instruments Technologies Limited | 1 |
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.