Thermaloy

Thermaloy Plus Preformed Expanded Arch MX/MN.016 X.022

Registry build 21.09.26
43manufacturers in China registered for this device type
146catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (15), Guangdong (9), Jiangsu (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZC
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
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Heilongjiang Rainbow Technology Co., Ltd. Jiamusi Heilongjiang Contract manufacturer 2
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25

Showing 12 of 43. All 43 manufacturers in China registered for Wire, Orthodontic

Record

Regulatory record for Thermaloy
Listed by RMO, United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-09-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Thermaloy
Catalogue number Size Per pack Status
A07726-1 10 In distribution
A07703 10 In distribution
A07075 10 In distribution
A07302 10 In distribution
A07303 10 In distribution
A07707 10 In distribution
A07721-1 10 In distribution
A07711 10 In distribution
A07372 10 In distribution
A07380 10 In distribution
A07721 10 In distribution
A07704 10 In distribution
E01246 10 In distribution
A07725 10 In distribution
A00678 10 In distribution
A07746 10 In distribution
A07307 10 In distribution
A07328 10 In distribution
A07322 10 In distribution
A07351 10 In distribution
A07308-1 10 In distribution
A07701 10 In distribution
A07700-1 10 In distribution
A07311-1 10 In distribution
A07360 10 In distribution
A07310 10 In distribution
A07377-1 10 In distribution
A07720 10 In distribution
A07354-1 10 In distribution
E07012-1 10 In distribution
A07700 10 In distribution
A07361-1 10 In distribution
A07308 10 In distribution
A07323 10 In distribution
E01243 10 In distribution
A07370 10 In distribution
A07748 10 In distribution
A00678 10 In distribution
A07728-1 10 In distribution
A00788 10 In distribution
A07749 10 In distribution
A07332-1 10 In distribution
A07327 10 In distribution
A07747 10 In distribution
A07706 10 In distribution
A07357 10 In distribution
A07731 10 In distribution
E07020-1 10 In distribution
A07334 10 In distribution
A07312-1 10 In distribution
A07729 10 In distribution
A07313 10 In distribution
A07335 10 In distribution
E07013-1 10 In distribution
A07314 10 In distribution
A07320 10 In distribution
A07373 10 In distribution
A07767 10 In distribution
A07730 10 In distribution
E01241 10 In distribution
A07356 10 In distribution
A07705 10 In distribution
A07301-1 10 In distribution
A07766 10 In distribution
A07729-1 10 In distribution
A07328-1 10 In distribution
A07706-1 10 In distribution
A07724 10 In distribution
A07701-1 10 In distribution
A07300-1 10 In distribution
A07376 10 In distribution
A07304 10 In distribution
E07022-1 10 In distribution
A07326-1 10 In distribution
A07325 10 In distribution
A07732 10 In distribution
A07323-1 10 In distribution
A07744 10 In distribution
A07763 10 In distribution
A07355-1 10 In distribution
A07357-1 10 In distribution
A07312 10 In distribution
A07331-1 10 In distribution
A07764 10 In distribution
A07724-1 10 In distribution
A07307-1 10 In distribution
A07704-1 10 In distribution
A07377 10 In distribution
A07748-1 10 In distribution
A07702 10 In distribution
A07725-1 10 In distribution
E07021-1 10 In distribution
A07723 10 In distribution
A07353 10 In distribution
A07322-1 10 In distribution
A07355 10 In distribution
A07303-1 10 In distribution
A04340 10 In distribution
A07302-1 10 In distribution
A07301 10 In distribution
A07708 10 In distribution
A00678 10 In distribution
A07370-1 10 In distribution
A07321-1 10 In distribution
A07333 10 In distribution
E01242 10 In distribution
A01433 10 In distribution
A07703-1 10 In distribution
E01247 10 In distribution
A07728 10 In distribution
A07324 10 In distribution
A07361 10 In distribution
A07330 10 In distribution
A07741 10 In distribution
A07709-1 10 In distribution
A07722 10 In distribution
A07708-1 10 In distribution
A07300 10 In distribution
A07712 10 In distribution
A07371 10 In distribution
A07710 10 In distribution
A07352 10 In distribution
A07330-1 10 In distribution
A07726 10 In distribution
A07709 10 In distribution
A07315 10 In distribution
A00677 10 In distribution
A07321 10 In distribution
E01249 10 In distribution
A07311 10 In distribution
A07354 10 In distribution
A07371-1 10 In distribution
A07325-1 10 In distribution
A07743 10 In distribution
A07331 10 In distribution
A07332 10 In distribution
A07304-1 10 In distribution
A07351-1 10 In distribution
A07324-1 10 In distribution
A07326 10 In distribution
A07727 10 In distribution
A07761 10 In distribution
A07310-1 10 In distribution
E01240 10 In distribution
A07723-1 10 In distribution
A07350 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wire, Orthodontic G & H Wire Company 2,746
Europa G & H Wire Company 2,409
Pg Supply PG Supply, Inc. 1,990
Trueform G & H Wire Company 1,984
G4 Nickel Titanium G & H Wire Company 957
Tanzo American Orthodontics 906
Aditek Aditek DO Brasil S/A 879
G4 Europa Nickel Titanium G & H Wire Company 819
3M™ Unitek™ 3M Unitek 729
Orthodontic wire Dentos, Incorporated 711
Orthoquest Young Innovations Inc. 698
NT3 American Orthodontics 694

Showing 12 of 679. All products under Wire, Orthodontic

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