COE®

COE® Stainless Steel-Solid Set of 8, Contains Numbers: S101, S103, S104, S105, S107, S120, S121, S122

Registry build 21.09.26
41manufacturers in China registered for this device type
400catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (8), Shanghai (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EBH
Manufacturer City Province Registered as Device types
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
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
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Tianjin Water Source Tech Co., Ltd. Tianjin Tianjin Manufacturer 27

Showing 12 of 41. All 41 manufacturers in China registered for Material, Impression Tray, Resin

Record

Regulatory record for COE®
Listed by GC America Inc., United States
FDA product code EBH
Device type Material, Impression Tray, Resin
Device class Class 1
Regulation 21 CFR 872.3670
Establishment Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2017-02-10
Record revised 2018-03-29 (version 2)

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
Packaging Case of 5, carton of 50, carton of 6, carton of 36
Distribution end date 2023-04-20

Catalogue Numbers

Catalogue numbers for COE®
Catalogue number Size Per pack Status
261571 In distribution
260411 In distribution
264122 In distribution
260991 In distribution
250201 12 In distribution
264041 In distribution
261011 In distribution
250311 12 In distribution
267001 50 In distribution
264921 In distribution
261221 In distribution
263483 In distribution
261682 In distribution
265111 In distribution
265008 In distribution
252112 432 In distribution
263682 In distribution
263571 In distribution
264031 In distribution
269141 In distribution
260031 In distribution
261321 In distribution
250321 12 In distribution
260471 In distribution
250012 432 In distribution
250712 432 In distribution
264071 In distribution
261471 In distribution
264321 In distribution
250071 12 In distribution
260871 In distribution
261681 In distribution
268011 In distribution
263672 In distribution
260028 In distribution
250326 72 In distribution
250201 12 In distribution
260311 In distribution
263583 In distribution
263481 In distribution
260651 In distribution
261484 In distribution
269008 In distribution
268041 In distribution
263584 In distribution
261671 In distribution
261211 In distribution
260018 In distribution
261583 In distribution
269241 In distribution
269221 In distribution
261572 In distribution
261311 In distribution
269211 In distribution
268201 In distribution
260451 In distribution
260201 In distribution
260048 In distribution
265112 In distribution
260141 In distribution
263584 In distribution
264107 In distribution
263681 In distribution
261221 In distribution
263673 In distribution
263684 In distribution
263674 In distribution
263481 In distribution
269211 In distribution
263582 In distribution
263581 In distribution
260211 In distribution
264911 In distribution
264331 In distribution
261091 In distribution
260808 In distribution
268221 In distribution
261331 In distribution
269008 In distribution
260331 In distribution
261573 In distribution
263573 In distribution
250076 72 In distribution
261572 In distribution
261584 In distribution
268041 In distribution
269091 In distribution
261672 In distribution
260091 In distribution
261673 In distribution
260441 In distribution
260481 In distribution
261681 In distribution
250112 432 In distribution
261041 In distribution
261683 In distribution
260421 In distribution
264051 In distribution
260841 In distribution
261672 In distribution
261301 In distribution
264103 In distribution
263581 In distribution
261331 In distribution
260040 In distribution
250041 12 In distribution
250016 72 In distribution
264105 In distribution
261871 In distribution
260621 In distribution
260621 In distribution
263572 In distribution
264008 In distribution
260461 In distribution
260691 In distribution
265014 In distribution
260241 In distribution
264121 In distribution
260991 In distribution
261482 In distribution
261483 In distribution
261241 In distribution
260851 In distribution
261211 In distribution
260241 In distribution
261481 In distribution
261241 In distribution
265013 In distribution
261472 In distribution
268006 In distribution
260051 In distribution
250011 12 In distribution
263684 In distribution
261051 In distribution
260881 In distribution
261031 In distribution
150001 50 In distribution
261582 In distribution
268201 In distribution
263485 In distribution
260331 In distribution
261584 In distribution
260891 In distribution
260041 In distribution
260641 In distribution
261581 In distribution
250412 432 In distribution
264211 In distribution
260071 In distribution
261684 In distribution
264311 In distribution
261473 In distribution
261684 In distribution
260031 In distribution
263210 In distribution
261472 In distribution
264120 In distribution
260431 In distribution
264108 In distribution
267001 50 In distribution
269071 In distribution
268071 In distribution
260016 In distribution
260048 In distribution
261482 In distribution
260841 In distribution
269141 In distribution
265011 In distribution
250041 12 In distribution
263583 In distribution
261023 In distribution
263471 In distribution
260051 In distribution
263672 In distribution
263106 In distribution
250301 12 In distribution
269241 In distribution
264010 In distribution
260611 In distribution
269221 In distribution
264311 In distribution
264004 In distribution
263484 In distribution
264010 In distribution
260811 In distribution
261485 In distribution
261018 In distribution
260011 In distribution
260801 In distribution
264321 In distribution
250216 72 In distribution
261201 In distribution
261071 In distribution
267201 50 In distribution
260304 In distribution
261991 In distribution
250221 12 In distribution
268071 In distribution
260281 In distribution
261091 In distribution
260321 In distribution
250096 12 In distribution
260671 In distribution
265012 In distribution
250211 12 In distribution
260608 In distribution
250046 72 In distribution
269051 In distribution
253112 432 In distribution
263473 In distribution
269281 In distribution
260861 In distribution
260681 In distribution
260141 In distribution
260808 In distribution
261674 In distribution
264008 In distribution
250206 72 In distribution
260631 In distribution
264101 In distribution
260481 In distribution
250071 12 In distribution
260671 In distribution
261481 In distribution
264221 In distribution
268011 In distribution
263682 In distribution
261011 In distribution
264108 In distribution
260301 In distribution
264031 In distribution
260301 In distribution
260408 In distribution
264041 In distribution
264104 In distribution
261071 In distribution
260028 In distribution
263471 In distribution
263683 In distribution
264105 In distribution
260018 In distribution
261023 In distribution
253212 432 In distribution
260421 In distribution
253012 432 In distribution
261201 In distribution
264107 In distribution
250306 72 In distribution
264211 In distribution
264221 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Power Dental USA Power Dental U.S.A. Inc. 56
Plasdent Plasdent Corp. 41
JMU JMU Dental, Inc 40
Vertex-Dental BV Vertex-Dental B.V. 34
COE Tray Plastic™ GC America Inc. 28
Ou Nuo Changzhou OU NUO Medical Equipment Co., Ltd. 28
Excellent Plasdent Corp. 22
Shining 3D® Hangzhou SHINING3D Dental Technology Co., Ltd. 17
Smart Dent ® Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. 17
Britedent Bright Supply Inc 16
iSmile Ismile Dental Products Inc. 15
Excellent-Colors Plasdent Corp. 13

Showing 12 of 197. All products under Material, Impression Tray, Resin

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