Stoma®

Composite instrument, Westcott, 115°, Ø 2,5mm-Ø 3,5mm, fig.21B

Registry build 21.09.26
23manufacturers in China registered for this device type
77catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Guangdong (5), Anhui (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 EIY
Manufacturer City Province Registered as Device types
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
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
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51

Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Filling, Plastic, Dental

Record

Regulatory record for Stoma®
Listed by Storz AM Mark Gmbh, Germany
FDA product code EIY
Device type Instrument, Filling, Plastic, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-08-27
Record revised 2020-09-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Stoma®
Catalogue number Size Status
2171.00 In distribution
12012.10 In distribution
2132.00 In distribution
2061.00 In distribution
7033.00 In distribution
7085.00 In distribution
2004.00 In distribution
7124.00 In distribution
2075.00 In distribution
2034.00 In distribution
2174.00 In distribution
7086.00 In distribution
2178.00 In distribution
7046.00 In distribution
12014.10 In distribution
2045.00 In distribution
2001.00 In distribution
7034.00 In distribution
2053.00 In distribution
2047.00 In distribution
2073.00 In distribution
2041.00 In distribution
7078.00 In distribution
2003.00 In distribution
2002.00 In distribution
2172.00 In distribution
2052.00 In distribution
2029.00 In distribution
7122.00 In distribution
2030.00 In distribution
2005.00 In distribution
2130.00 In distribution
2043.00 In distribution
2124.00 In distribution
2044.00 In distribution
2125.00 In distribution
2167.00 In distribution
7013.21 In distribution
2173.00 In distribution
7048.00 In distribution
2090.00 In distribution
7045.00 In distribution
7004.00 In distribution
13312.30 In distribution
7044.00 In distribution
7076.00 In distribution
7047.00 In distribution
2169.00 In distribution
2123.00 In distribution
7087.00 In distribution
12011.10 In distribution
7003.00 In distribution
7002.00 In distribution
7061.00 In distribution
2028.00 In distribution
7081.00 In distribution
2046.00 In distribution
7014.21 In distribution
12013.11 In distribution
7077.00 In distribution
2042.00 In distribution
7084.00 In distribution
7082.00 In distribution
12014.11 In distribution
2072.00 In distribution
12013.10 In distribution
2035.00 In distribution
2170.00 In distribution
2131.00 In distribution
13312.00 In distribution
12011.11 In distribution
2033.00 In distribution
2057.00 In distribution
7150.01 In distribution
2051.00 In distribution
2071.00 In distribution
2091.00 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hu-Friedy HU-Friedy MFG Co., LLC 355
Power Dental USA Power Dental U.S.A. Inc. 111
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 107
Reicodent Devemed Gmbh 91
American Eagle Instruments American Eagle Instruments 79
Zoll-Dental Zoll-Dental 69
Aesculap Aesculap AG 60
devemed Devemed Gmbh 58
Osung MND Osung MND Co., Ltd. 57
Integra® Miltex® Integra LifeSciences Production Corporation 41
Karl Schumacher Karl Schumacher Dental, LLC 38
A. Titan Instruments A. Titan Instruments, Inc. 34

Showing 12 of 109. All products under Instrument, Filling, Plastic, Dental

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