Penta-Morphic

Pentamor AR ELG NAR Taper 16X22

Registry build 21.09.26
43manufacturers in China registered for this device type
40catalogue 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 Penta-Morphic
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 2024-08-19

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, serial number

Catalogue Numbers

Catalogue numbers for Penta-Morphic
Catalogue number Size Per pack Status
E01500 10 In distribution
E01533 10 In distribution
E01537 10 In distribution
E01501 10 In distribution
E01522 10 In distribution
E01048 10 In distribution
E00553 10 In distribution
E01530 10 In distribution
E00651 10 In distribution
E01534 10 In distribution
E01503 10 In distribution
E01538 10 In distribution
E01523 10 In distribution
E01010 10 In distribution
E00661 10 In distribution
E01508 10 In distribution
E01023 10 In distribution
E01539 10 In distribution
E01520 10 In distribution
E00654 10 In distribution
E01509 10 In distribution
E01505 10 In distribution
E01507 10 In distribution
E01524 10 In distribution
E01502 10 In distribution
E01504 10 In distribution
E01521 10 In distribution
E01020 10 In distribution
E01536 10 In distribution
E01535 10 In distribution
E01513 10 In distribution
E01532 10 In distribution
E00552 10 In distribution
E01512 10 In distribution
E00554 10 In distribution
E01531 10 In distribution
E01510 10 In distribution
E01506 10 In distribution
E01511 10 In distribution
E01514 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