Affinity™ Monophase 2pk

Catalogue number 025400, listed by Clinician'S Choice Dental Products, Inc., Canada, under Syringe, Restorative And Impression Material. 49 manufacturers in China are registered for this product code.

Registry build 21.09.26
49manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (12), Guangdong (8), Anhui (7). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EID
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
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Nanchang White Technology Co., Ltd. Nanchang Jiangxi Contract manufacturer 21
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Shanghai Bing FAN Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 5
medmix China Ltd Shanghai Shanghai 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

Showing 12 of 49. All 49 manufacturers in China registered for Syringe, Restorative And Impression Material

Record

Regulatory record for Affinity™ Monophase 2pk
Listed by Clinician’S Choice Dental Products, Inc., Canada
FDA product code EID
Device type Syringe, Restorative And Impression Material
Device class Class 1
Regulation 21 CFR 872.4565
Record published 2016-09-16
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Min Relative Humidity. Ensure Adequate Ventilation; Storage environment temperature 65 to 75 °F; Storage environment temperature 18 to 24 °C
Sizes Total volume 50 ml
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Affinity™ Monophase 2pk
Catalogue number Size Status
025400 Total Volume 50 ml In distribution

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. 92
Henry Schein Henry Schein, Inc. 44
Accessory Bisco, Inc. 26
Mixing Tips Kettenbach Gmbh & Co KG 20
Defend Young Innovations Inc. 20
Plasdent Plasdent Corp. 19
Mixing Tips Kerr Corporation 18
Health-Tec/DHP Mixing Tips Dental Health Products Inc 17
Advance Dental Products THE Atlanta Dental Supply Company 17
Aeliteflo Bisco, Inc. 16
Mixing tips Voco Gmbh 15
3M™ RelyX™ 3M Deutschland GmbH 15

Showing 12 of 575. All products under Syringe, Restorative And Impression Material

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