Avalign

Dunn-Dautrey Type Anterior Condylar Retractor

Registry build 21.09.26
45manufacturers in China registered for this device type
28catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (10), Zhejiang (8), Shanghai (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIG
Manufacturer City Province Registered as Device types
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Dongguan Junhai Medical Device Co., Ltd. Dong Guang Guangdong Contract manufacturer 9
Forefront (Xiamen) Medical Devices Co., Ltd. Xiamen Fujian Contract manufacturer 8
Taizhou Polus Technology Co., Ltd. Taizhou Zhejiang Contract manufacturer 2
Talent Technology Mould Co., Limited Shenzhen Guangdong Contract manufacturer 1
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60

Showing 12 of 45. All 45 manufacturers in China registered for Retractor, All Types

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code EIG
Device type Retractor, All Types
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-09-28
Record revised 2023-07-06 (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 Avalign
Catalogue number Size Status
VM95-0835 In distribution
VM96-2261 In distribution
VM95-0031 In distribution
VM95-0837 In distribution
VM96-1413 In distribution
VM96-1957 In distribution
VM95-0059 In distribution
VM95-0033 In distribution
VM95-0833 In distribution
VM95-0035 In distribution
VM95-0073 In distribution
VM96-1515 In distribution
VM96-1411 In distribution
VM96-1499 In distribution
VM95-0071 In distribution
VM96-1193 In distribution
VM95-0043 In distribution
VM95-0057 In distribution
VM95-0017 In distribution
VM99-1227 In distribution
VM95-0039 In distribution
VM96-1009 In distribution
VM95-0037 In distribution
VM96-2253 In distribution
VM96-1604 In distribution
VM96-1495 In distribution
VM96-1511 In distribution
VM95-0041 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 340
Retractor, All Types George Tiemann & Co. 218
Retractor KLS-Martin L.P. 210
Zoll-Dental Zoll-Dental 110
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 90
ACE Ace Surgical Supply Co., Inc. 88
Millennium Avalign Technologies, Inc. 86
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 83
Retractor, All Types Biomet Microfixation 78
HU-Friedy HU-Friedy MFG Co., LLC 63
Kohdent Kohler Medizintechnik GmbH 61
Power Dental USA Power Dental U.S.A. Inc. 59

Showing 12 of 336. All products under Retractor, All Types

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