SmartPractice

Finn Chambers on Scanpor ATOPY 12mm, 50X5, 50/box

Registry build 21.09.26
186manufacturers in China registered for this device type
21catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (40), Jiangsu (35), Guangdong (32). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KXF
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Weihai Shandong Contract manufacturer 26
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Goodwood Medical Care Ltd Dalian Liaoning Contract manufacturer 19
Hangzhou Aosi Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 18
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15

Showing 12 of 186. All 186 manufacturers in China registered for Applicator, Absorbent Tipped, Non-Sterile

Record

Regulatory record for SmartPractice
Listed by Smarthealth, Inc.
FDA product code KXF
Device type Applicator, Absorbent Tipped, Non-Sterile
Device class Class 1
Regulation 21 CFR 880.6025
510(k) K013820
Record published 2020-12-15
Record revised 2025-04-22 (version 4)

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
Storage Special storage condition: Keep away from sunlight. Keep dry.

Catalogue Numbers

Catalogue numbers for SmartPractice
Catalogue number Size Per pack Status
AL7220 100 In distribution
AL7014 200 In distribution
AL7014PP 200 In distribution
AL71300 100 In distribution
AL7006 100 In distribution
AL7012 50 In distribution
AL7005 50 In distribution
AL7100 1,000 In distribution
AL7001PP 100 In distribution
AL7001 100 In distribution
AL7120PP 100 In distribution
AL7002 50 In distribution
AL7201 200 In distribution
AL17320GEN 50 In distribution
AL7200 1,000 In distribution
AL7004PP 100 In distribution
AL71200 100 In distribution
AL7003PP 150 In distribution
AL7110 200 In distribution
AL7000 25 In distribution
AL7210 200 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Puritan® Puritan Medical Products Company LLC 36
JMU JMU Dental, Inc 22
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 21
Cardinal Health Cardinal Health 200, LLC 16
Avanos Avanos Medical, Inc. 16
Q-Care Sage Products LLC 13
Ballard™ SunMed Group Holdings, LLC 13
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 10
Alleset GRI Medical & Electronic Technology Co., Ltd. 10
Puritan® PurFlock Ultra® Puritan Medical Products Company LLC 9
Plasdent Plasdent Corp. 9
AMD-Ritmed Solon AMD Medicom Inc. 9

Showing 12 of 98. All products under Applicator, Absorbent Tipped, Non-Sterile

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