Burkhart Dental Supply

Impression Tray Clear #4 Medium Lower (12)

Registry build 21.09.26
73manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Shanghai (11), Jiangsu (10). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EHY
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Cixi Qimei Combination Tool Packing Factory Cixi Shanghai Contract manufacturer 10
Yongqing Huaguan Dental Instruments Factory Langfang Hebei Contract manufacturer 9

Showing 12 of 73. All 73 manufacturers in China registered for Tray, Impression, Preformed

Record

Regulatory record for Burkhart Dental Supply
Listed by Burkhart Dental Supply Co., THE
FDA product code EHY
Device type Tray, Impression, Preformed
Device class Class 1
Regulation 21 CFR 872.6880
Premarket notification Exempt
Record published 2022-04-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for Burkhart Dental Supply
Catalogue number Size Status
72722004 In distribution
72721007 In distribution
72722007 In distribution
72722008 In distribution
72722003 In distribution
72721004 In distribution
72721005 In distribution
72722002 In distribution
72722009 In distribution
72722006 In distribution
72721002 In distribution
72721008 In distribution
72722001 In distribution
72721003 In distribution
72721006 In distribution
72722005 In distribution
72721001 In distribution
72721009 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OneBite Evolution Precision Dental Products, LLC 114
Astek Young Innovations Inc. 102
Benco Benco Dental Supply Co. 63
Osung MND Osung MND Co., Ltd. 56
Premium Plus Premium Plus (Dongguan) Limited 54
devemed Devemed Gmbh 47
Reicodent Devemed Gmbh 47
Blue Sky Bio, LLC Blue SKY BIO, LLC 47
Darby Dental Supply, LLC Darby Dental Supply, LLC 45
Tray, Impression, Preformed YDM Corporation 42
Premium Plus Premium Plus International Limited 41
Advance Dental Products THE Atlanta Dental Supply Company 31

Showing 12 of 595. All products under Tray, Impression, Preformed

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