GUM®

Super TIP Soft/Compact, Proxabrush GO-Betweens

Registry build 21.09.26
244manufacturers in China registered for this device type
64catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (66), Guangdong (66), Zhejiang (37). 34 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EFW
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Nanchang White Technology Co., Ltd. Nanchang Jiangxi Contract manufacturer 21
Goodwood Medical Care Ltd Dalian Liaoning Contract manufacturer 19
Bandex Industrial Corp. Zhuhai Guangdong Contract manufacturer 14
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Foshan Guangdong Contract manufacturer 11
Lianyungang Brilliant Industrial Co., Ltd. Lianyungang Jiangsu Contract manufacturer 10
Dongguan Junhai Medical Device Co., Ltd. Dong Guang Guangdong Contract manufacturer 9
Fansheng Technology (Guangdong) Co., Ltd. Zhongshan Guangdong Contract manufacturer 8
Yangzhou Yichuan Plastic Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 8
Jiangsu Sanxiao Group Co., Ltd. Yangzhou Jiangsu Contract manufacturer 7

Showing 12 of 244. All 244 manufacturers in China registered for Toothbrush, Manual

Record

Regulatory record for GUM®
Listed by Sunstar Americas, Inc., United States
FDA product code EFW
Device type Toothbrush, Manual
Device class Class 1
Regulation 21 CFR 872.6855
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-11-10
Record revised 2025-04-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Packaging Box of 36, bag of 6, bag of 60, bag of 40, bag of 24, bag of 48
Sizes Height 6.86 to 208.6 mm; width 6.86 to 33 mm; depth 5.94 to 91.95 mm; height 190 m
Distribution end date 2026-07-21

Catalogue Numbers

Catalogue numbers for GUM®
Catalogue number Size Per pack Status
158 Height 186 mm In distribution
612 Height 75.44 mm 48 In distribution
614 Height 24.05 mm 8 In distribution
157 Height 186 mm In distribution
874 16 In distribution
614 Depth 6.86 mm In distribution
618 Width 6.86 mm In distribution
3014 Width 19.95 mm In distribution
1614 Width 33 mm In distribution
625 Height 208.6 mm In distribution
461 Height 69.95 mm In distribution
3612 Height 7.2 mm In distribution
874 Width 7.2 mm 4 In distribution
414 Width 6.86 mm 8 In distribution
3615 In distribution
871 Depth 7.2 mm 40 In distribution
612 Width 6.86 mm 200 In distribution
3614 Width 7.2 mm In distribution
877 Height 69.95 mm 10 In distribution
230 Height 124.5 mm In distribution
153 Width 20.6 mm 2 In distribution
612 Depth 6.86 mm In distribution
874 Width 7.2 mm 8 In distribution
3612 Depth 7.2 mm 40 In distribution
3614 Width 7.2 mm 10 In distribution
872 Width 7.2 mm 40 In distribution
153 Height 186 mm In distribution
125 Width 20.6 mm In distribution
872 Height 75.44 mm In distribution
3612 Width 7.2 mm 10 In distribution
872 Depth 7.2 mm 15 In distribution
871 Width 7.2 mm In distribution
3614 Depth 7.2 mm 15 In distribution
462 Height 69.95 mm In distribution
618 Height 24.05 mm 200 In distribution
1612 Width 33 mm In distribution
3612 Width 7.2 mm 15 In distribution
414 Height 75.44 mm 48 In distribution
460 Height 69.95 mm In distribution
614 Width 6.86 mm 200 In distribution
614 Width 6.86 mm 16 In distribution
612 Height 24.05 mm 8 In distribution
614 Height 75.44 mm 48 In distribution
124 In distribution
1618 Height 75.44 mm In distribution
470 Height 69.95 mm In distribution
871 Height 75.44 mm 40 In distribution
228 Width 21.6 mm 2 In distribution
872 Height 75.44 mm 40 In distribution
871 Depth 7.2 mm 10 In distribution
871 Height 75.44 mm 15 In distribution
3614 Height 7.2 mm 40 In distribution
471 Height 69.95 mm In distribution
3614 Width 7.2 mm 40 In distribution
228 Width 21.6 mm In distribution
3612 Depth 7.2 mm 10 In distribution
90291 28 In distribution
1312 Width 7.2 mm In distribution
872 Height 75.44 mm 10 In distribution
472 Height 69.95 mm In distribution
414 Height 6.86 mm 2 In distribution
3615 Withdrawn
3615 Withdrawn
3615 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dr. Brown’s Dr. Brown’s Company 40
Henry Schein Henry Schein, Inc. 37
The Orthodontic Store Young Innovations Inc. 22
e-sarang B & B Medical Technologies, Inc. 19
Plak Smacker Young Innovations Inc. 13
Quala National Distribution & Contracting Inc 13
PRO-SYS Benco Dental Supply Co. 12
Ubbi Huizhou LVB Maternal & Infant Supplies Co., Ltd. 10
Dream by 3D Dental 3D Dental Designs AND Development, LLC 9
Rexall Dolgencorp, LLC 8
Orthoquest Young Innovations Inc. 7
Morelli Dental Morelli Ltda. 7

Showing 12 of 211. All products under Toothbrush, Manual

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