Stoma®

Spare rubb. jaws , red, 20 pairs, f. 5430.00,5435.00, 5451.00

Registry build 21.09.26
64manufacturers in China registered for this device type
80catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZN
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Acot Plastics (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 8
medmix China Ltd Shanghai Shanghai Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99

Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand

Record

Regulatory record for Stoma®
Listed by Storz AM Mark Gmbh, Germany
FDA product code DZN
Device type Instruments, Dental Hand
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
5410.00 In distribution
13371.40 In distribution
7195.00 In distribution
13375.03 In distribution
7242.00 In distribution
1787.10 In distribution
2918.20 In distribution
2242.20 In distribution
13307.00 In distribution
3386.12 In distribution
5451.01 In distribution
12243.20 In distribution
3256.08 In distribution
2187.00 In distribution
2246.00 In distribution
14670.00 In distribution
12223.00 In distribution
7216.00 In distribution
2243.20 In distribution
14612.00 In distribution
7243.30 In distribution
12246.20 In distribution
14645.00 In distribution
12216.00 In distribution
7242.30 In distribution
3984.02 In distribution
3387.10 In distribution
2242.00 In distribution
13375.01 In distribution
14671.00 In distribution
2188.00 In distribution
2211.00 In distribution
7981.00 In distribution
14616.00 In distribution
6092.00 In distribution
14630.00 In distribution
2919.10 In distribution
12225.00 In distribution
13309.10 In distribution
14613.00 In distribution
12221.00 In distribution
7242.20 In distribution
7242.10 In distribution
12231.00 In distribution
1784.10 In distribution
7243.00 In distribution
14635.00 In distribution
3255.15 In distribution
1782.10 In distribution
3386.34 In distribution
7243.10 In distribution
13376.02 In distribution
2186.00 In distribution
3256.10 In distribution
2189.00 In distribution
12242.20 In distribution
12247.20 In distribution
6088.24 In distribution
1786.10 In distribution
14614.00 In distribution
1785.10 In distribution
14642.00 In distribution
3710.00 In distribution
2246.20 In distribution
1781.10 In distribution
2243.00 In distribution
3386.00 In distribution
12244.20 In distribution
2210.00 In distribution
7246.00 In distribution
5455.00 In distribution
7920.00 In distribution
14634.00 In distribution
3984.03 In distribution
1783.10 In distribution
5452.00 In distribution
3256.00 In distribution
2255.00 In distribution
14618.00 In distribution
12241.20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LMDental LM-Dental 936
A. Titan Instruments A. Titan Instruments, Inc. 544
Instruments, Dental Hand Hager & Meisinger Gesellschaft mit beschränkter Haftung 307
Power Dental USA Power Dental U.S.A. Inc. 209
Supremo Instrumentos Andre Gregate Braga Instrumentos Ltda 95
Henry Schein Henry Schein, Inc. 93
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 92
Diamodent Diamodent 81
Nordent Manufacturing Inc Nordent Manufacturing Inc 77
Brasseler USA Peter Brasseler Holdings, LLC 67
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 58
Darby Dental Supply, LLC Darby Dental Supply, LLC 53

Showing 12 of 1,362. All products under Instruments, Dental Hand

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