TruFlex™

TRUFLEX TAD Coil Spring 12mm Light .009"x.030",100gms force 10/pk

Registry build 21.09.26
43manufacturers in China registered for this device type
271catalogue 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 TruFlex™
Listed by Ortho Organizers, Inc., United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-09-30
Record revised 2025-12-30 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for TruFlex™
Catalogue number Size Per pack Status
2000-136 10 In distribution
700-102 3 In distribution
5000-104 10 In distribution
5000-213 10 In distribution
5001-207 10 In distribution
5001-102 10 In distribution
5000-204 10 In distribution
6000-312 10 In distribution
5001-205 10 In distribution
2005-105 10 In distribution
6000-112 10 In distribution
6000-111 10 In distribution
900-105L 10 In distribution
2004-103 10 In distribution
6000-107 10 In distribution
D6000-207 10 In distribution
D6001-149 10 In distribution
D6001-050 10 In distribution
700-105H 10 In distribution
6000-405 10 In distribution
2000-132 10 In distribution
6001-041 10 In distribution
700-101 3 In distribution
6000-101 10 In distribution
6000-412 10 In distribution
6000-204 10 In distribution
5000-307 10 In distribution
6001-050 10 In distribution
6000-208 10 In distribution
5000-402 10 In distribution
5000-101 10 In distribution
6000-300 10 In distribution
6000-203 10 In distribution
6000-102 10 In distribution
D6000-209 10 In distribution
6001-146 10 In distribution
2004-107 10 In distribution
D6000-113 10 In distribution
2004-103ST 10 In distribution
6000-108 10 In distribution
6001-047 10 In distribution
5000-406 10 In distribution
2000-142 10 In distribution
6000-109 10 In distribution
D6001-148 10 In distribution
D6001-016 10 In distribution
5001-210 10 In distribution
6000-003 In distribution
700-103 3 In distribution
5000-107 10 In distribution
2000-118 10 In distribution
2000-103 10 In distribution
6001-142 10 In distribution
2000-101 10 In distribution
D6001-143 10 In distribution
6001-014 10 In distribution
5000-102 10 In distribution
6001-118 10 In distribution
2004-108ST 10 In distribution
5001-103 10 In distribution
2004-104ST 10 In distribution
900-104H 10 In distribution
2004-102ST 10 In distribution
2005-101 10 In distribution
5001-203 10 In distribution
D6001-146 10 In distribution
6001-141 10 In distribution
5000-111 10 In distribution
5001-108 10 In distribution
6000-002 In distribution
6000-307 10 In distribution
2000-140 10 In distribution
6000-202 10 In distribution
2000-128 10 In distribution
5000-304 10 In distribution
2000-122 10 In distribution
2005-108 10 In distribution
6001-042 10 In distribution
6000-210 10 In distribution
2005-101ST 10 In distribution
6001-018 10 In distribution
6000-205 10 In distribution
2000-130 10 In distribution
6001-020 10 In distribution
6001-150 10 In distribution
700-001 In distribution
D6000-112 10 In distribution
D6001-140 10 In distribution
900-105H 10 In distribution
5000-105 10 In distribution
D6001-141 10 In distribution
5001-202 10 In distribution
2005-108ST 10 In distribution
D6000-110 10 In distribution
6000-301 10 In distribution
6001-049 10 In distribution
2001-114 10 In distribution
5001-109 10 In distribution
6001-016 10 In distribution
6001-116 10 In distribution
6000-404 10 In distribution
6001-114 10 In distribution
2005-106ST 10 In distribution
2005-102ST 10 In distribution
2001-116 10 In distribution
5000-303 10 In distribution
6000-201 10 In distribution
5000-403 10 In distribution
2000-134 10 In distribution
D6001-018 10 In distribution
2005-107 10 In distribution
D6001-041 10 In distribution
2000-126 10 In distribution
D6000-105 10 In distribution
700-105M 10 In distribution
6000-110 10 In distribution
6001-144 10 In distribution
5001-111 10 In distribution
5001-211 10 In distribution
2004-101ST 10 In distribution
6000-103 10 In distribution
5000-401 10 In distribution
5001-208 10 In distribution
5000-106 10 In distribution
5000-404 10 In distribution
2000-138 10 In distribution
700-105L 10 In distribution
5000-412 10 In distribution
D6000-106 10 In distribution
5000-301 10 In distribution
5000-203 10 In distribution
D6001-147 10 In distribution
5001-106 10 In distribution
2000-102 10 In distribution
6000-401 10 In distribution
5001-209 10 In distribution
2005-103 10 In distribution
D6001-014 10 In distribution
6000-212 10 In distribution
6000-306 10 In distribution
5000-400 10 In distribution
2004-105 10 In distribution
2005-105ST 10 In distribution
6000-105 10 In distribution
6001-149 10 In distribution
2001-216 10 In distribution
2000-116 10 In distribution
2001-104 10 In distribution
5000-202 10 In distribution
2001-118 10 In distribution
D6000-103 10 In distribution
5000-302 10 In distribution
D6000-208 10 In distribution
D6001-150 10 In distribution
D6000-203 10 In distribution
6000-302 10 In distribution
D6000-204 10 In distribution
2004-107ST 10 In distribution
D6000-213 10 In distribution
6000-400 10 In distribution
900-104M 10 In distribution
5001-213 10 In distribution
D6000-210 10 In distribution
5000-405 10 In distribution
2005-104 10 In distribution
6000-206 10 In distribution
2001-103 10 In distribution
D6000-107 10 In distribution
2004-104 10 In distribution
6000-001 In distribution
5000-306 10 In distribution
5000-300 10 In distribution
5000-407 10 In distribution
D6001-043 10 In distribution
D6001-048 10 In distribution
2004-102 10 In distribution
5000-112 10 In distribution
D6000-104 10 In distribution
D6001-142 10 In distribution
6000-209 10 In distribution
6001-040 10 In distribution
2004-101 10 In distribution
6000-406 10 In distribution
2000-114 10 In distribution
2004-106ST 10 In distribution
700-000 In distribution
6000-305 10 In distribution
6000-207 10 In distribution
6000-403 10 In distribution
D6001-047 10 In distribution
D6000-201 10 In distribution
D6001-116 10 In distribution
5000-212 10 In distribution
900-104L 10 In distribution
700-104L 10 In distribution
5001-104 10 In distribution
2005-104ST 10 In distribution
6001-143 10 In distribution
D6001-114 10 In distribution
5000-110 10 In distribution
D6000-102 10 In distribution
6000-113 10 In distribution
2004-105ST 10 In distribution
D6000-206 10 In distribution
2005-103ST 10 In distribution
5001-107 10 In distribution
6000-402 10 In distribution
D6000-111 10 In distribution
D6001-118 10 In distribution
6000-000 In distribution
5000-109 10 In distribution
D6001-042 10 In distribution
D6001-144 10 In distribution
2005-102 10 In distribution
6001-046 10 In distribution
2005-106 10 In distribution
5001-204 10 In distribution
6001-048 10 In distribution
900-105M 10 In distribution
5000-205 10 In distribution
5000-211 10 In distribution
5000-113 10 In distribution
D6000-108 10 In distribution
5000-201 10 In distribution
6001-120 10 In distribution
D6000-109 10 In distribution
D6001-046 10 In distribution
6000-106 10 In distribution
6000-407 10 In distribution
2001-102 10 In distribution
5000-207 10 In distribution
6000-303 10 In distribution
5000-210 10 In distribution
700-104H 10 In distribution
6000-304 10 In distribution
6000-213 10 In distribution
5000-305 10 In distribution
D6000-202 10 In distribution
5000-206 10 In distribution
6001-148 10 In distribution
6001-147 10 In distribution
5000-108 10 In distribution
700-104M 10 In distribution
5001-206 10 In distribution
D6001-040 10 In distribution
6000-104 10 In distribution
6000-211 10 In distribution
2004-106 10 In distribution
2005-107ST 10 In distribution
6001-043 10 In distribution

Showing 250 of 271 catalogue numbers.

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