Who else makes this device?

Name: Midway Select
Brand: Midway Select

Midway Select · Gutta-Percha → Dental

42manufacturers in China registered for this device type

70catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Shanghai (8), Jiangsu (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EKM
Manufacturer	City	Province	Registered as	Device types
Shenzhen Denco Medical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	52
Hantech Medical Device Co., Ltd.	Cixi	Zhejiang	Contract manufacturer	18
Dentsply Dental (Tianjin) Co., Ltd.	Teda	Tianjin	Contract manufacturer	2
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
Wuxi Lyusmile IMP AND EXP Co., Ltd.	Wuxi	Jiangsu	Private-label distributor	66
Hubei Guarddent Medical Technology Co., Ltd.	Wuhan	Hubei	Manufacturer	60
Tribest Dental Products Co Ltd	Yangzhong	Jiangsu	Contract manufacturer	58
Shenzhen Rogin Medical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	51
Anqing Clean Dental Instrument Technology Co., Ltd.	Anqing	Anhui	Manufacturer	50
Shanghai Dochem Industries Co., Ltd.	Shanghai	Shanghai	Manufacturer	45

Showing 12 of 42. All 42 manufacturers in China registered for Gutta-Percha

Record

Regulatory record for Midway Select
Listed by	Midway Dental Supply, LLC
FDA product code	EKM
Device type	Gutta-Percha
Device class	Class 1
Regulation	21 CFR 872.3850
Premarket notification	Exempt
Record published	2021-04-05
Record revised	2026-05-20 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2026-05-01

Catalogue Numbers

Catalogue numbers for Midway Select
Catalogue number	Per pack	Status
002-0542		Withdrawn
002-0508		Withdrawn
002-0506	200	Withdrawn
002-0509	100	Withdrawn
002-0556		Withdrawn
002-0512	100	Withdrawn
002-0563	60	Withdrawn
002-0554	60	Withdrawn
002-0523	100	Withdrawn
002-0539	120	Withdrawn
002-0511	100	Withdrawn
002-0534	120	Withdrawn
002-0557		Withdrawn
002-0510	100	Withdrawn
002-0551	60	Withdrawn
002-0524	100	Withdrawn
002-0521		Withdrawn
002-0501	200	Withdrawn
002-0515	100	Withdrawn
002-0498	200	Withdrawn
002-0526	100	Withdrawn
002-0540	120	Withdrawn
002-0497	200	Withdrawn
002-0502	200	Withdrawn
002-0525	100	Withdrawn
002-0522		Withdrawn
002-0560	60	Withdrawn
002-0559	60	Withdrawn
002-0518	100	Withdrawn
002-0536	120	Withdrawn
002-0500	200	Withdrawn
002-0543		Withdrawn
002-0558	60	Withdrawn
002-0529		Withdrawn
002-0530	120	Withdrawn
002-0527	100	Withdrawn
002-0538	120	Withdrawn
002-0544	60	Withdrawn
002-0549	60	Withdrawn
002-0546	60	Withdrawn
002-0499	200	Withdrawn
002-0547	60	Withdrawn
002-0514	100	Withdrawn
002-0517	100	Withdrawn
002-0545	60	Withdrawn
002-0528	100	Withdrawn
002-0541	120	Withdrawn
002-0507		Withdrawn
002-0550	60	Withdrawn
002-0548	60	Withdrawn
002-0513	100	Withdrawn
002-0555	60	Withdrawn
002-0504	200	Withdrawn
002-0533	120	Withdrawn
002-0505	200	Withdrawn
002-0516	100	Withdrawn
002-0535	120	Withdrawn
002-0496	200	Withdrawn
002-0552	60	Withdrawn
002-0495	200	Withdrawn
002-0503	200	Withdrawn
002-0564		Withdrawn
002-0519	100	Withdrawn
002-0520	100	Withdrawn
002-0561	60	Withdrawn
002-0537	120	Withdrawn
002-0562	60	Withdrawn
002-0553	60	Withdrawn
002-0531	120	Withdrawn
002-0532	120	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Gutta Percha Points	Diadent Group Intl., Inc.	1,404
MM Marked Gutta Percha Points	Diadent Group Intl., Inc.	683
Henry Schein	Henry Schein, Inc.	386
Zarc	Shanghai Xing YU Medical Equipment Co., Ltd.	166
Darby Dental Supply, LLC	Darby Dental Supply, LLC	130
Brasseler USA	Peter Brasseler Holdings, LLC	126
Avalon Biomed	Shanghai Xing YU Medical Equipment Co., Ltd.	106
Advance Dental Products	THE Atlanta Dental Supply Company	97
Safco gutta percha points	Safco Dental Supply	90
Sure-endo	Sure Dent Corporation	89
3D Endo	3D Dental Designs AND Development, LLC	82
Endodontic Obturators	Tulsa Dental Products LLC	78

Showing 12 of 599. All products under Gutta-Percha

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.

Midway Select

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies