Zooby

Zooby Fluoride Free Prophy Paste, Chocolate Chow, Medium Grit

Registry build 21.09.26
25manufacturers in China registered for this device type
27catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (6), Guangxi (4), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJR
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Liaoning Upcera Co., Ltd. Benxi Liaoning Contract manufacturer 10
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34

Showing 12 of 25. All 25 manufacturers in China registered for Agent, Polishing, Abrasive, Oral Cavity

Record

Regulatory record for Zooby
Listed by Young Dental Manufacturing I, LLC
FDA product code EJR
Device type Agent, Polishing, Abrasive, Oral Cavity
Device class Class 1
Regulation 21 CFR 872.6030
Premarket notification Exempt
Record published 2022-10-16
Record revised 2024-04-15 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Bag of 100, case of 12, package, inner pack, case
Distribution end date 2024-04-12

Catalogue Numbers

Catalogue numbers for Zooby
Catalogue number Size Status
605010 In distribution
602010 In distribution
603110 In distribution
606010 In distribution
605210 In distribution
602110 In distribution
603210 In distribution
999302 In distribution
603010 In distribution
600010 In distribution
601210 In distribution
296210 In distribution
606110 In distribution
604010 In distribution
296209 In distribution
601110 In distribution
296213 In distribution
604110 In distribution
60021S In distribution
601010 In distribution
602210 In distribution
604210 In distribution
606210 In distribution
605110 In distribution
296211 In distribution
600210 In distribution
600110 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Strauss Diamond Diamond Strauss Instruments Inc 319
Henry Schein Henry Schein, Inc. 56
Nupro® Prophylaxis Paste with Fluoride Dentsply LLC 44
Waterpik Prophy Paste Water PIK, Inc. 38
D-Lish Young Dental Manufacturing I, LLC 32
Gelato Keystone Industries 28
Topex® Prophy Paste Dentsply LLC 27
Enamel Pro® Prophy Paste Premier Dental Products Co. 26
AIR-Flow E.M.S. Electro Medical Systems S.A. 24
Sparkle Prophylaxis Paste Crosstex International 22
CleanJoy Voco Gmbh 21
Ena Shiny Micerium SPA 20

Showing 12 of 341. All products under Agent, Polishing, Abrasive, Oral Cavity

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