Ismile

VP Air/Water Syringe Tip Assorted Colors

Registry build 21.09.26
56manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (10), Shanghai (9). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ECB
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Yongqing Huaguan Dental Instruments Factory Langfang Hebei Contract manufacturer 9
Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd. Tianjin Tianjin Contract manufacturer 6
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
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82

Showing 12 of 56. All 56 manufacturers in China registered for Unit, Syringe, Air And/Or Water

Record

Regulatory record for iSmile
Listed by Ismile Dental Products Inc., United States
FDA product code ECB
Device type Unit, Syringe, Air And/Or Water
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2023-06-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for iSmile
Catalogue number Size Per pack Status
45-1040 250 In distribution
45-1043 250 In distribution
45-1041 250 In distribution
45-1042 250 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DCI Parts DCI International, LLC 80
Astek Young Innovations Inc. 31
DCI DCI International, LLC 29
Crystal Tip Young Innovations Inc. 26
Natures Tip Young Innovations Inc. 22
Sani-Tip® Dentsply Professional 19
A-dec A-dec, Inc. 15
Essentials by 3D Dental 3D Dental Designs AND Development, LLC 14
Henry Schein Henry Schein, Inc. 12
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 12
Darby Dental Supply, LLC Darby Dental Supply, LLC 11
Starz Tipz Young Innovations Inc. 11

Showing 12 of 77. All products under Unit, Syringe, Air And/Or Water

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer