GUM®

US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental…

Registry build 21.09.26

US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental Brush 1 x 3612PQ Proxabrush Moderate Interdental Brush 1 x 650PA Soft Pick Advanced Interdental Pick 1 x 308PD End Tuft Toothbrush 1 x 600PYC Rubber Tip Stimulator 1 x 760PB Tongue Cleaner /Scraper 1 x 895 PQ Crayola Kids Flosser 1 x 227A Crayola Marker Toothbrush

151manufacturers in China registered for this device type
85catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (44), Guangdong (35), Zhejiang (28). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JES
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12
Yuyao NEW Power Promotion Industrial Co., Ltd. Yuyao Zhejiang Contract manufacturer 8
Yangzhou Yichuan Plastic Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 8
Yangzhou Star Oral Care Product Co., Ltd. Yangzhou Jiangsu Contract manufacturer 7
HI-P (Xiamen) Precision Plastic Manufacturing Co., Xiamen Fujian Contract manufacturer 6
Kingkey MBC Life Technology Group Co., Ltd. Shantou Guangdong Contract manufacturer 6
Yuyao Clean Commodity Co., Ltd. Yuyao Zhejiang Contract manufacturer 6
Hayco Industries (Shenzhen) Ltd. Shenzhen Guangdong Contract manufacturer 5
Yantai Yulong Commodity Co., Ltd. Yantai Shandong Contract manufacturer 5

Showing 12 of 151. All 151 manufacturers in China registered for Floss, Dental

Record

Regulatory record for GUM®
Listed by Sunstar Americas, Inc., United States
FDA product code JES
Device type Floss, Dental
Device class Class 1
Regulation 21 CFR 872.6390
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-11-10
Record revised 2024-05-02 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 144, box of 96, bag of 6, bag of 540, box of 4, box
Sizes Height 31.5 to 468 mm; width 16.73 to 68.65 mm; depth 1.75 to 16 mm

Catalogue Numbers

Catalogue numbers for GUM®
Catalogue number Size Per pack Status
885 Height 39.98 mm 60 In distribution
3210 Height 49.9 mm 6 In distribution
888 Width 68.65 mm 90 In distribution
828 Height 39.98 mm 270 In distribution
891 Height 39.98 mm 3 In distribution
4110 Height 75.8 mm 4 In distribution
4110 Height 75.8 mm 2 In distribution
840 Height 95.25 mm 25 In distribution
828 Height 39.98 mm 90 In distribution
896 Height 70.81 mm 40 In distribution
2014 Height 31.5 mm 144 In distribution
KIT57 In distribution
9934 In distribution
893 Height 39.98 mm 90 In distribution
4100 Height 200.7 mm In distribution
KIT34 In distribution
897 Height 39.98 mm 75 In distribution
9935 36 In distribution
887 Height 39.98 mm 2 In distribution
515 Height 31.5 mm 144 In distribution
2008 Height 49.9 mm 2 In distribution
4100 In distribution
887 Height 39.98 mm 120 In distribution
KIT36 In distribution
1115 Width 33 mm 144 In distribution
9940 In distribution
821 Height 78.51 mm 2 In distribution
KIT58 In distribution
828 600 In distribution
857 Height 60 mm 75 In distribution
1815 Height 31.5 mm 144 In distribution
99184 In distribution
KIT591 In distribution
1840 Height 49.9 mm In distribution
821 Height 78.51 mm 60 In distribution
888 Width 68.65 mm 3 In distribution
2030 6 In distribution
2010 Height 31.5 mm 144 In distribution
885 Height 39.98 mm 2 In distribution
KIT525 In distribution
845 Height 120.4 mm In distribution
ORTHKITPRB In distribution
KIT505 In distribution
2030 Height 31.5 mm 144 In distribution
891 Height 39.98 mm 40 In distribution
90033 In distribution
1940 Height 49.9 mm In distribution
KIT461 In distribution
4100 In distribution
KIT153 In distribution
3200 Height 49.9 mm In distribution
9691 In distribution
1415 Height 31.5 mm 144 In distribution
895 Height 70.81 mm 3 In distribution
KIT33 In distribution
KIT35 In distribution
840 150 In distribution
90199 In distribution
887 Height 39.98 mm 90 In distribution
4110 Height 75.8 mm 2 In distribution
892 Height 39.98 mm 50 In distribution
840 Height 95.25 mm 5 In distribution
1840 Height 49.9 mm In distribution
898 Height 81.6 mm 75 In distribution
888 Width 68.65 mm 150 In distribution
KIT59 In distribution
KIT56 In distribution
898 Height 81.6 mm 2 In distribution
2030 Height 49.9 mm In distribution
KIT135 In distribution
4100 Width 16.73 mm In distribution
2030 Height 49.9 mm 40 In distribution
2008 Height 31.5 mm 144 In distribution
1916 Height 49.9 mm In distribution
828 Height 39.98 mm 150 In distribution
859 Height 70.81 mm 90 In distribution
2030 Height 49.9 mm 2 In distribution
828 Height 39.98 mm 3 In distribution
4110 Height 75.8 mm 4 In distribution
KIT234 In distribution
3200 Height 468 mm 5 In distribution
828 Height 39.98 mm 450 In distribution
889 Height 39.98 mm 150 In distribution
2006 Height 49.9 mm 2 In distribution
1812 Height 49.9 mm 2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 30
PRO-SYS Benco Dental Supply Co. 22
Meijer Meijer, Inc. 16
CareOne Ahold U.S.A., Inc. 14
Quala National Distribution & Contracting Inc 13
Waxed Dental Floss Safco Dental Supply 12
Core Values Harmon Stores, Inc. 12
CVS Health Woonsocket Prescription Center, Incorporated 11
TopCare Topco Associates, LLC 11
Publix Publix Super Markets, Inc. 11
E-Z Slide Dental Floss Maxill, Inc. 11
Rite Aid Pharmacy Rite AID Corporation 10

Showing 12 of 188. All products under Floss, Dental

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