Orthos
ORTHOS CM CUNITI 35ARCH 20x20 UPSM PK/10
43manufacturers in China registered for this device type
121catalogue numbers in this listing
1510(k) clearance
1recall
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.
| 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
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 0.016 to 0.02 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 219-2110 | Wire size 017X025 inches | 10 | In distribution |
| 219-3103 | Outer Diameter.016 in | 10 | In distribution |
| 219-4211 | Wire size 020X020 inches | 10 | In distribution |
| 219-0104 | Outer Diameter.018 in | 10 | In distribution |
| 219-4111 | Wire size 020X020 inches | 10 | In distribution |
| 219-4303 | Outer Diameter.016 in | 10 | In distribution |
| 219-1212 | Wire size 019X025 inches | 10 | In distribution |
| 219-1313 | Wire size 021X025 inches | 10 | In distribution |
| 219-4404 | Outer Diameter.018 in | 10 | In distribution |
| 219-2413 | Wire size 021X025 inches | 10 | In distribution |
| 219-4113 | Wire size 021X025 inches | 10 | In distribution |
| 219-3412 | Wire size 019X025 inches | 10 | In distribution |
| 219-5108 | Wire size 016X022 inches | 10 | In distribution |
| 219-4212 | Wire size 019X025 inches | 10 | In distribution |
| 219-1310 | Wire size 017X025 inches | 10 | In distribution |
| 219-4109 | Wire size 017X017 inches | 10 | In distribution |
| 219-4304 | Outer Diameter.018 in | 10 | In distribution |
| 219-4204 | Outer Diameter.018 in | 10 | In distribution |
| 219-2112 | Wire size 019X025 inches | 10 | In distribution |
| 219-3212 | Wire size 019X025 inches | 10 | In distribution |
| 219-1108 | Wire size 016X022 inches | 10 | In distribution |
| 219-2113 | Wire size 021X025 inches | 10 | In distribution |
| 219-3108 | Wire size 016X022 inches | 10 | In distribution |
| 219-4103 | Outer Diameter.016 in | 10 | In distribution |
| 219-2313 | Wire size 021X025 inches | 10 | In distribution |
| 219-4208 | Wire size 016X022 inches | 10 | In distribution |
| 219-3410 | Wire size 017X025 inches | 10 | In distribution |
| 219-5112 | Wire size 019X025 inches | 10 | In distribution |
| 219-1580 | Outer Diameter.016 in | 10 | In distribution |
| 219-3210 | Wire size 017X025 inches | 10 | In distribution |
| 219-1570 | Outer Diameter.016 in | 10 | In distribution |
| 219-1110 | Wire size 017X025 inches | 10 | In distribution |
| 219-4112 | Wire size 019X025 inches | 10 | In distribution |
| 219-4309 | Wire size 017X017 inches | 10 | In distribution |
| 219-1592 | Outer Diameter.02 in | 10 | In distribution |
| 219-4213 | Wire size 021X025 inches | 10 | In distribution |
| 219-3112 | Wire size 019X025 inches | 10 | In distribution |
| 219-2408 | Wire size 016X022 inches | 10 | In distribution |
| 219-3308 | Wire size 016X022 inches | 10 | In distribution |
| 219-3208 | Wire size 016X022 inches | 10 | In distribution |
| 219-5408 | Wire size 016X022 inches | 10 | In distribution |
| 219-2310 | Wire size 017X025 inches | 10 | In distribution |
| 219-1111 | Wire size 018X025 inches | 10 | In distribution |
| 219-1308 | Wire size 016X022 inches | 10 | In distribution |
| 219-2312 | Wire size 019X025 inches | 10 | In distribution |
| 219-1311 | Wire size 018X025 inches | 10 | In distribution |
| 219-2108 | Wire size 016X022 inches | 10 | In distribution |
| 219-4203 | Outer Diameter.016 in | 10 | In distribution |
| 219-4311 | Wire size 020X020 inches | 10 | In distribution |
| 219-1560 | Outer Diameter.016 in | 10 | In distribution |
| 219-1312 | Wire size 019X025 inches | 10 | In distribution |
| 219-4312 | Wire size 019X025 inches | 10 | In distribution |
| 219-3204 | Outer Diameter.018 in | 10 | In distribution |
| 219-1412 | Wire size 019X025 inches | 10 | In distribution |
| 219-6310 | Wire size 017X025 inches | 10 | In distribution |
| 219-4313 | Wire size 021X025 inches | 10 | In distribution |
| 219-0404 | Outer Diameter.018 in | 10 | In distribution |
| 219-4108 | Wire size 016X022 inches | 10 | In distribution |
| 219-5412 | Wire size 019X025 inches | 10 | In distribution |
| 219-3304 | Outer Diameter.018 in | 10 | In distribution |
| 219-3110 | Wire size 017X025 inches | 10 | In distribution |
| 219-4413 | Wire size 021X025 inches | 10 | In distribution |
| 219-0304 | Outer Diameter.018 in | 10 | In distribution |
| 219-3404 | Outer Diameter.018 in | 10 | In distribution |
| 219-4308 | Wire size 016X022 inches | 10 | In distribution |
| 219-1413 | Wire size 021X025 inches | 10 | In distribution |
| 219-1113 | Wire size 021X025 inches | 10 | In distribution |
| 219-1112 | Wire size 019X025 inches | 10 | In distribution |
| 219-4408 | Wire size 016X022 inches | 10 | In distribution |
| 219-5208 | Wire size 016X022 inches | 10 | In distribution |
| 219-1591 | Outer Diameter.018 in | 10 | In distribution |
| 219-2213 | Wire size 021X025 inches | 10 | In distribution |
| 219-2208 | Wire size 016X022 inches | 10 | In distribution |
| 219-5213 | Wire size 021X025 inches | 10 | In distribution |
| 219-2410 | Wire size 017X025 inches | 10 | In distribution |
| 219-0204 | Outer Diameter.018 in | 10 | In distribution |
| 219-1561 | Outer Diameter.018 in | 10 | In distribution |
| 219-2210 | Wire size 017X025 inches | 10 | In distribution |
| 219-3104 | Outer Diameter.018 in | 10 | In distribution |
| 219-4411 | Wire size 020X020 inches | 10 | In distribution |
| 219-1590 | Outer Diameter.016 in | 10 | In distribution |
| 219-3408 | Wire size 016X022 inches | 10 | In distribution |
| 219-4110 | Wire size 017X025 inches | 10 | In distribution |
| 219-2308 | Wire size 016X022 inches | 10 | In distribution |
| 219-5308 | Wire size 016X022 inches | 10 | In distribution |
| 219-5310 | Wire size 017X025 inches | 10 | In distribution |
| 219-3203 | Outer Diameter.016 in | 10 | In distribution |
| 219-3312 | Wire size 019X025 inches | 10 | In distribution |
| 219-5110 | Wire size 017X025 inches | 10 | In distribution |
| 219-1208 | Wire size 016X022 inches | 10 | In distribution |
| 219-1408 | Wire size 016X022 inches | 10 | In distribution |
| 219-1210 | Wire size 017X025 inches | 10 | In distribution |
| 219-3403 | Outer Diameter.016 in | 10 | In distribution |
| 219-6410 | Wire size 017X025 inches | 10 | In distribution |
| 219-5312 | Wire size 019X025 inches | 10 | In distribution |
| 219-2212 | Wire size 019X025 inches | 10 | In distribution |
| 219-1562 | Outer Diameter.02 in | 10 | In distribution |
| 219-4409 | Wire size 017X017 inches | 10 | In distribution |
| 219-4310 | Wire size 017X025 inches | 10 | In distribution |
| 219-4209 | Wire size 017X017 inches | 10 | In distribution |
| 219-6210 | Wire size 017X025 inches | 10 | In distribution |
| 219-1581 | Outer Diameter.018 in | 10 | In distribution |
| 219-1411 | Wire size 018X025 inches | 10 | In distribution |
| 219-4210 | Wire size 017X025 inches | 10 | In distribution |
| 219-4410 | Wire size 017X025 inches | 10 | In distribution |
| 219-3310 | Wire size 017X025 inches | 10 | In distribution |
| 219-5113 | Wire size 021X025 inches | 10 | In distribution |
| 219-3303 | Outer Diameter.016 in | 10 | In distribution |
| 219-1572 | Outer Diameter.02 in | 10 | In distribution |
| 219-1410 | Wire size 017X025 inches | 10 | In distribution |
| 219-1211 | Wire size 018X025 inches | 10 | In distribution |
| 219-2412 | Wire size 019X025 inches | 10 | In distribution |
| 219-4104 | Outer Diameter.018 in | 10 | In distribution |
| 219-5410 | Wire size 017X025 inches | 10 | In distribution |
| 219-4403 | Outer Diameter.016 in | 10 | In distribution |
| 219-6110 | Wire size 017X025 inches | 10 | In distribution |
| 219-1571 | Outer Diameter.018 in | 10 | In distribution |
| 219-5210 | Wire size 017X025 inches | 10 | In distribution |
| 219-1582 | Outer Diameter.02 in | 10 | In distribution |
| 219-4412 | Wire size 019X025 inches | 10 | In distribution |
| 219-5212 | Wire size 019X025 inches | 10 | In distribution |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112640 | 2011-11-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-15 | Not classified | Packaging | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. | 23 Packs | 2012-03-08 |
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.