3m™ Unitek™

3M™ Unitek™ Nitinol CLevel Anchoragessic Archwire 4297-609, OrthoForm™ Level Anchorage, Upper, .017x.025, Unit of Use, 10/Pk

Registry build 21.09.26
43manufacturers in China registered for this device type
729catalogue 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 3M™ Unitek™
Listed by 3M Unitek, United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2022-12-08
Record revised 2021-02-05 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for 3M™ Unitek™
Catalogue number Size Per pack Status
305-164 In distribution
4300-015 50 In distribution
295-371 10 In distribution
4581-3215 10 In distribution
4300-023 50 In distribution
4581-3275 10 In distribution
298-116 10 In distribution
4583-302 10 In distribution
4582-303 10 In distribution
4297-705 10 In distribution
4582-301 10 In distribution
4297-977 10 In distribution
300-481 10 In distribution
314-127 In distribution
4296-181 10 In distribution
9293-918 10 In distribution
4581-318 10 In distribution
9293-905 10 In distribution
9296-612 10 In distribution
241-528 10 In distribution
4581-3175 10 In distribution
294-102 50 In distribution
4300-006 50 In distribution
4297-923 10 In distribution
4300-025 50 In distribution
4297-704 10 In distribution
4297-609 10 In distribution
4297-615 10 In distribution
9293-879 10 In distribution
251-722 10 In distribution
4293-711 10 In distribution
4581-3195 10 In distribution
211-260 30 In distribution
4297-834 10 In distribution
4300-005 50 In distribution
4296-308 10 In distribution
4581-3155 10 In distribution
4581-3255 10 In distribution
9296-653 10 In distribution
4296-808 10 In distribution
211-240 30 In distribution
298-275 10 In distribution
4301-354 10 In distribution
4297-978 10 In distribution
4297-703 10 In distribution
4297-701 10 In distribution
256-725 10 In distribution
314-125 In distribution
4581-319 10 In distribution
4297-833 10 In distribution
9296-807 10 In distribution
4301-323 10 In distribution
4300-625 50 In distribution
4297-832 10 In distribution
4301-322 10 In distribution
4581-330 10 In distribution
300-823 10 In distribution
4300-626 50 In distribution
4297-808 10 In distribution
260-175 10 In distribution
4585-3035 10 In distribution
299-166 50 In distribution
340-011 5 In distribution
4297-867 10 In distribution
9296-611 10 In distribution
4581-303 10 In distribution
301-162 50 In distribution
260-150 10 In distribution
4301-316 10 In distribution
298-375 10 In distribution
211-120 40 In distribution
390-090 1,000 In distribution
4297-604 10 In distribution
299-185 50 In distribution
9296-651 10 In distribution
4297-622 10 In distribution
253-722 10 In distribution
4297-953 10 In distribution
4582-302 10 In distribution
4300-022 50 In distribution
4581-3095 10 In distribution
4297-984 10 In distribution
4297-281 10 In distribution
9296-646 10 In distribution
4296-809 10 In distribution
362-287 10 In distribution
4581-3335 10 In distribution
364-400 10 In distribution
4301-314 10 In distribution
4581-324 10 In distribution
4297-172 10 In distribution
4297-715 10 In distribution
4582-304 10 In distribution
4585-308 10 In distribution
4581-3235 10 In distribution
314-224 In distribution
4296-182 10 In distribution
216-220 30 In distribution
4297-956 10 In distribution
4300-621 50 In distribution
4296-518 10 In distribution
4297-610 10 In distribution
9297-857 10 In distribution
4297-975 10 In distribution
4585-3075 10 In distribution
4301-303 10 In distribution
4585-3015 10 In distribution
4297-917 10 In distribution
4300-612 50 In distribution
4585-314 10 In distribution
4297-711 10 In distribution
4297-814 10 In distribution
211-320 25 In distribution
9296-517 10 In distribution
9293-935 10 In distribution
251-616 10 In distribution
362-241 10 In distribution
4297-959 10 In distribution
4581-302 10 In distribution
4300-030 10 In distribution
4296-913 10 In distribution
390-100 1,000 In distribution
256-622 10 In distribution
9296-520 10 In distribution
308-002 In distribution
9296-645 10 In distribution
4297-957 10 In distribution
9293-919 10 In distribution
253-822 10 In distribution
314-226 In distribution
4581-328 10 In distribution
4585-301 10 In distribution
4301-317 10 In distribution
4585-302 10 In distribution
4296-915 10 In distribution
9296-911 10 In distribution
9293-954 10 In distribution
253-228 10 In distribution
211-510 15 In distribution
314-222 In distribution
4297-802 10 In distribution
300-821 10 In distribution
9296-806 10 In distribution
340-007 5 In distribution
4300-618 50 In distribution
4300-611 50 In distribution
4297-861 10 In distribution
9296-647 10 In distribution
251-925 10 In distribution
4296-121 10 In distribution
4297-816 10 In distribution
4582-306 10 In distribution
4583-308 10 In distribution
4293-701 10 In distribution
211-210 40 In distribution
4297-920 10 In distribution
709-060 In distribution
9293-816 10 In distribution
256-825 10 In distribution
9293-881 10 In distribution
4583-304 10 In distribution
295-111 10 In distribution
4296-979 10 In distribution
4297-974 10 In distribution
390-080 1,000 In distribution
4581-3225 10 In distribution
4296-521 10 In distribution
4297-859 10 In distribution
4585-3085 10 In distribution
218-280 10 In distribution
218-450 6 In distribution
256-616 10 In distribution
4297-913 10 In distribution
4297-616 10 In distribution
295-482 10 In distribution
300-794 10 In distribution
4297-961 10 In distribution
4581-313 10 In distribution
4296-161 10 In distribution
4296-815 10 In distribution
9293-860 10 In distribution
9293-907 10 In distribution
9296-615 10 In distribution
4300-016 50 In distribution
300-761 10 In distribution
4297-993 10 In distribution
4297-481 10 In distribution
4297-854 10 In distribution
300-272 10 In distribution
300-788 10 In distribution
300-785 10 In distribution
4297-836 10 In distribution
4300-007 50 In distribution
297-826 10 In distribution
305-156 In distribution
9293-913 10 In distribution
9293-851 10 In distribution
4297-813 10 In distribution
4296-985 10 In distribution
4296-911 10 In distribution
4296-412 10 In distribution
314-126 In distribution
340-002 5 In distribution
216-100 30 In distribution
4297-718 10 In distribution
314-128 In distribution
4300-615 50 In distribution
4585-3125 10 In distribution
9293-956 10 In distribution
4296-406 10 In distribution
9293-893 10 In distribution
4582-305 10 In distribution
256-925 10 In distribution
4296-523 10 In distribution
4296-122 10 In distribution
4297-614 10 In distribution
211-200 40 In distribution
9297-858 10 In distribution
4301-309 10 In distribution
297-822 10 In distribution
9293-822 10 In distribution
4585-304 10 In distribution
4300-628 50 In distribution
4296-986 10 In distribution
9297-955 10 In distribution
314-221 In distribution
9296-518 10 In distribution
4585-313 10 In distribution
4581-3075 10 In distribution
4296-520 10 In distribution
297-825 10 In distribution
4583-312 10 In distribution
4300-017 50 In distribution
9296-627 10 In distribution
295-281 10 In distribution
4583-310 10 In distribution
4297-707 10 In distribution
4300-616 50 In distribution
9296-634 10 In distribution
216-160 30 In distribution
218-300 10 In distribution
4296-303 10 In distribution
9293-815 10 In distribution
390-110 1,000 In distribution
216-120 30 In distribution
200-094 In distribution
301-182 50 In distribution
258-616 10 In distribution
4296-991 10 In distribution
294-162 50 In distribution

Showing 250 of 300 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
Orthodontic wire Dentos, Incorporated 711
Orthoquest Young Innovations Inc. 698
NT3 American Orthodontics 694
Wires & Accessories World Class Technology Corporation 692

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