Ormco
Universal Lower Second Bicuspid Band With LUG Size 17
27manufacturers in China registered for this device type
257catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (17), Jiangsu (4), Guangdong (4). 6 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 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| 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 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Band, Preformed, Orthodontic
Record
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
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 number | Size | Per pack | Status |
|---|---|---|---|
| 331-0109 | Band Size 9 | In distribution | |
| 332-0313 | Band Size 13 | In distribution | |
| 676-3673 | 036 X 072 inches | In distribution | |
| 088-4013 | In distribution | ||
| 088-4012 | In distribution | ||
| 332-0325 | Band Size 25 | In distribution | |
| 676-3672 | 036 X 072 inches | In distribution | |
| 331-0312 | Band Size 12 | In distribution | |
| 331-0302 | Band Size 2 | In distribution | |
| 331-0103 | Band Size 3 | In distribution | |
| 330-0131 | Band Size 31 | In distribution | |
| 330-0130 | Band Size 30 | In distribution | |
| 422-0104 | Width 456, Height 268 | 5 | In distribution |
| 088-4008 | In distribution | ||
| 331-0331 | Band Size 31 | In distribution | |
| 332-0322 | Band Size 22 | In distribution | |
| 330-0317 | Band Size 17 | In distribution | |
| 421-0006 | Width 465, Height 28 | 5 | In distribution |
| 414-0003 | Width 298, Height 33 | 5 | In distribution |
| 331-0121 | Band Size 21 | In distribution | |
| 332-0107 | Band Size 7 | In distribution | |
| 332-0106 | Band Size 6 | In distribution | |
| 330-0320 | Band Size 20 | In distribution | |
| 331-0102 | Band Size 2 | In distribution | |
| 332-0127 | Band Size 27 | In distribution | |
| 672-3672 | 036 X 072 inches | In distribution | |
| 704-4013 | Sheath 036 inches | 25 | In distribution |
| 330-0308 | Band Size 8 | In distribution | |
| 414-0106 | Width 36, Height 36 | 5 | In distribution |
| 331-0126 | Band Size 26 | In distribution | |
| 332-0307 | Band Size 7 | In distribution | |
| 330-0328 | Band Size 28 | In distribution | |
| 332-0331 | Band Size 31 | In distribution | |
| 330-0331 | Band Size 31 | In distribution | |
| 332-0129 | Band Size 29 | In distribution | |
| 674-3672 | 036 X 072 inches | In distribution | |
| 331-0128 | Band Size 28 | In distribution | |
| 331-0310 | Band Size 10 | In distribution | |
| 330-0324 | Band Size 24 | In distribution | |
| 422-0102 | Width 416, Height 248 | 5 | In distribution |
| 331-0129 | Band Size 29 | In distribution | |
| 331-0304 | Band Size 4 | In distribution | |
| 331-0116 | Band Size 16 | In distribution | |
| 332-0119 | Band Size 19 | In distribution | |
| 330-0309 | Band Size 9 | In distribution | |
| 332-0309 | Band Size 9 | In distribution | |
| 422-0004 | Width 456, Height 268 | 5 | In distribution |
| 330-0105 | Band Size 5 | In distribution | |
| 332-0116 | Band Size 16 | In distribution | |
| 414-0001 | Width 256, Height 31 | 5 | In distribution |
| 672-3060 | 030 X 060 inches | In distribution | |
| 331-0118 | Band Size 18 | In distribution | |
| 330-0316 | Band Size 16 | In distribution | |
| 330-0119 | Band Size 19 | In distribution | |
| 331-0110 | Band Size 10 | In distribution | |
| 331-0332 | Band Size 32 | In distribution | |
| 421-0004 | Width 427, Height 26 | 5 | In distribution |
| 332-0101 | Band Size 1 | In distribution | |
| 331-0107 | Band Size 7 | In distribution | |
| 330-0124 | Band Size 24 | In distribution | |
| 332-0321 | Band Size 21 | In distribution | |
| 331-0307 | Band Size 7 | In distribution | |
| 421-0105 | Width 446, Height 270 | 5 | In distribution |
| 331-0112 | Band Size 12 | In distribution | |
| 331-0327 | Band Size 27 | In distribution | |
| 331-0120 | Band Size 20 | In distribution | |
| 330-0321 | Band Size 21 | In distribution | |
| 330-0313 | Band Size 13 | In distribution | |
| 330-0113 | Band Size 13 | In distribution | |
| 088-4019 | In distribution | ||
| 422-0001 | Width 396, Height 238 | 5 | In distribution |
| 330-0306 | Band Size 6 | In distribution | |
| 330-0132 | Band Size 32 | In distribution | |
| 330-0315 | Band Size 15 | In distribution | |
| 330-0111 | Band Size 11 | In distribution | |
| 331-0130 | Band Size 30 | In distribution | |
| 421-0007 | Width 484, Height 29 | 5 | In distribution |
| 330-0307 | Band Size 7 | In distribution | |
| 331-0122 | Band Size 22 | In distribution | |
| 332-0125 | Band Size 25 | In distribution | |
| 332-0122 | Band Size 22 | In distribution | |
| 332-0318 | Band Size 18 | In distribution | |
| 422-0006 | Width 496, Height 288 | 5 | In distribution |
| 332-0131 | Band Size 31 | In distribution | |
| 331-0127 | Band Size 27 | In distribution | |
| 330-0128 | Band Size 28 | In distribution | |
| 330-0120 | Band Size 20 | In distribution | |
| 332-0323 | Band Size 23 | In distribution | |
| 330-0318 | Band Size 18 | In distribution | |
| 330-0107 | Band Size 7 | In distribution | |
| 332-0329 | Band Size 29 | In distribution | |
| 330-0332 | Band Size 32 | In distribution | |
| 134-0001 | 10 | In distribution | |
| 331-0111 | Band Size 11 | In distribution | |
| 331-0104 | Band Size 4 | In distribution | |
| 421-0008 | Width 503, Height 3 | 5 | In distribution |
| 332-0303 | Band Size 3 | In distribution | |
| 088-4001 | In distribution | ||
| 331-0316 | Band Size 16 | In distribution | |
| 421-0103 | Width 408, Height 250 | 5 | In distribution |
| 330-0117 | Band Size 17 | In distribution | |
| 331-0105 | Band Size 5 | In distribution | |
| 675-3671 | 036 X 072 inches | In distribution | |
| 330-0329 | Band Size 29 | In distribution | |
| 331-0306 | Band Size 6 | In distribution | |
| 088-4007 | In distribution | ||
| 332-0328 | Band Size 28 | In distribution | |
| 330-0129 | Band Size 29 | In distribution | |
| 331-0326 | Band Size 26 | In distribution | |
| 332-0108 | Band Size 8 | In distribution | |
| 330-0123 | Band Size 23 | In distribution | |
| 331-0320 | Band Size 20 | In distribution | |
| 332-0308 | Band Size 8 | In distribution | |
| 331-0114 | Band Size 14 | In distribution | |
| 332-0120 | Band Size 20 | In distribution | |
| 330-0330 | Band Size 30 | In distribution | |
| 331-0305 | Band Size 5 | In distribution | |
| 332-0330 | Band Size 30 | In distribution | |
| 421-0107 | Width 484, Height 290 | 5 | In distribution |
| 331-0123 | Band Size 23 | In distribution | |
| 332-0316 | Band Size 16 | In distribution | |
| 414-0006 | Width 361, Height 36 | 5 | In distribution |
| 332-0317 | Band Size 17 | In distribution | |
| 331-0313 | Band Size 13 | In distribution | |
| 678-3672 | 036 X 072 inches | 10 | In distribution |
| 422-0101 | Width 396, Height 238 | 5 | In distribution |
| 332-0102 | Band Size 2 | In distribution | |
| 330-0314 | Band Size 14 | In distribution | |
| 421-0108 | Width 503, Height 300 | 5 | In distribution |
| 672-3000 | 40 | In distribution | |
| 332-0310 | Band Size 10 | In distribution | |
| 421-0001 | Width 37, Height 23 | 5 | In distribution |
| 332-0327 | Band Size 27 | In distribution | |
| 330-0323 | Band Size 23 | In distribution | |
| 332-0103 | Band Size 3 | In distribution | |
| 331-0119 | Band Size 19 | In distribution | |
| 414-0105 | Width 34, Height 35 | 5 | In distribution |
| 332-0118 | Band Size 18 | In distribution | |
| 331-0314 | Band Size 14 | In distribution | |
| 330-0108 | Band Size 8 | In distribution | |
| 414-0004 | Width 319, Height 34 | 5 | In distribution |
| 421-0005 | Width 446, Height 27 | 5 | In distribution |
| 330-0118 | Band Size 18 | In distribution | |
| 332-0315 | Band Size 15 | In distribution | |
| 422-0107 | Width 516, Height 298 | 5 | In distribution |
| 422-0103 | Width 436, Height 258 | 5 | In distribution |
| 330-0125 | Band Size 25 | In distribution | |
| 331-0317 | Band Size 17 | In distribution | |
| 331-0324 | Band Size 24 | In distribution | |
| 331-0323 | Band Size 23 | In distribution | |
| 331-0322 | Band Size 22 | In distribution | |
| 332-0324 | Band Size 24 | In distribution | |
| 422-0008 | Width 536, Height 308 | 5 | In distribution |
| 675-3673 | 036 X 072 inches | In distribution | |
| 331-0303 | Band Size 3 | In distribution | |
| 332-0304 | Band Size 4 | In distribution | |
| 332-0104 | Band Size 4 | In distribution | |
| 332-0306 | Band Size 6 | In distribution | |
| 422-0106 | Width 496, Height 288 | 5 | In distribution |
| 676-3671 | 036 X 072 inches | In distribution | |
| 331-0125 | Band Size 25 | In distribution | |
| 422-0007 | Width 516, Height 298 | 5 | In distribution |
| 422-0002 | Width 416, Height 248 | 5 | In distribution |
| 332-0117 | Band Size 17 | In distribution | |
| 331-0330 | Band Size 30 | In distribution | |
| 331-0101 | Band Size 1 | In distribution | |
| 615-0301 | In distribution | ||
| 331-0311 | Band Size 11 | In distribution | |
| 088-4052 | In distribution | ||
| 330-0122 | Band Size 22 | In distribution | |
| 421-0002 | Width 389, Height 24 | 5 | In distribution |
| 330-0310 | Band Size 10 | In distribution | |
| 134-0010 | 10 | In distribution | |
| 332-0111 | Band Size 11 | In distribution | |
| 332-0332 | Band Size 32 | In distribution | |
| 331-0113 | Band Size 13 | In distribution | |
| 332-0319 | Band Size 19 | In distribution | |
| 414-0005 | Width 34, Height 35 | 5 | In distribution |
| 331-0132 | Band Size 32 | In distribution | |
| 330-0319 | Band Size 19 | In distribution | |
| 421-0003 | Width 408, Height 25 | 5 | In distribution |
| 330-0106 | Band Size 6 | In distribution | |
| 332-0302 | Band Size 2 | In distribution | |
| 332-0114 | Band Size 14 | In distribution | |
| 330-0112 | Band Size 12 | In distribution | |
| 331-0309 | Band Size 9 | In distribution | |
| 330-0325 | Band Size 25 | In distribution | |
| 330-0114 | Band Size 14 | In distribution | |
| 422-0005 | Width 476, Height 278 | 5 | In distribution |
| 088-4020 | In distribution | ||
| 330-0121 | Band Size 21 | In distribution | |
| 331-0308 | Band Size 8 | In distribution | |
| 330-0110 | Band Size 10 | In distribution | |
| 332-0128 | Band Size 28 | In distribution | |
| 331-0319 | Band Size 19 | In distribution | |
| 330-0327 | Band Size 27 | In distribution | |
| 421-0101 | Width 370, Height 230 | 5 | In distribution |
| 331-0301 | Band Size 1 | In distribution | |
| 332-0326 | Band Size 26 | In distribution | |
| 331-0117 | Band Size 17 | In distribution | |
| 332-0121 | Band Size 21 | In distribution | |
| 414-0103 | Width 298, Height 33 | 5 | In distribution |
| 330-0116 | Band Size 16 | In distribution | |
| 414-0101 | Width 256, Height 31 | 5 | In distribution |
| 330-0322 | Band Size 22 | In distribution | |
| 332-0320 | Band Size 20 | In distribution | |
| 332-0130 | Band Size 30 | In distribution | |
| 332-0312 | Band Size 12 | In distribution | |
| 332-0314 | Band Size 14 | In distribution | |
| 414-0002 | Width 277, Height 32 | 5 | In distribution |
| 330-0115 | Band Size 15 | In distribution | |
| 332-0123 | Band Size 23 | In distribution | |
| 330-0305 | Band Size 5 | In distribution | |
| 332-0124 | Band Size 24 | In distribution | |
| 422-0105 | Width 476, Height 278 | 5 | In distribution |
| 330-0312 | Band Size 12 | In distribution | |
| 331-0315 | Band Size 15 | In distribution | |
| 332-0105 | Band Size 5 | In distribution | |
| 331-0329 | Band Size 29 | In distribution | |
| 088-4051 | In distribution | ||
| 331-0108 | Band Size 8 | In distribution | |
| 332-0301 | Band Size 1 | In distribution | |
| 331-0131 | Band Size 31 | In distribution | |
| 331-0321 | Band Size 21 | In distribution | |
| 088-4006 | In distribution | ||
| 331-0106 | Band Size 6 | In distribution | |
| 675-3672 | 036 X 072 inches | In distribution | |
| 414-0102 | Width 277, Height 32 | 5 | In distribution |
| 421-0106 | Width 465, Height 280 | 5 | In distribution |
| 330-0109 | Band Size 9 | In distribution | |
| 673-3672 | 036 X 072 inches | In distribution | |
| 088-4018 | In distribution | ||
| 332-0115 | Band Size 15 | In distribution | |
| 677-3672 | 036 X 072 inches | 10 | In distribution |
| 414-0104 | Width 319, Height 34 | 5 | In distribution |
| 332-0126 | Band Size 26 | In distribution | |
| 088-4009 | In distribution | ||
| 422-0108 | Width 536, Height 308 | 5 | In distribution |
| 331-0115 | Band Size 15 | In distribution | |
| 332-0110 | Band Size 10 | In distribution | |
| 332-0311 | Band Size 11 | In distribution | |
| 330-0311 | Band Size 11 | In distribution | |
| 331-0328 | Band Size 28 | In distribution | |
| 332-0112 | Band Size 12 | In distribution | |
| 422-0003 | Width 436, Height 258 | 5 | In distribution |
| 332-0305 | Band Size 5 | In distribution | |
| 330-0326 | Band Size 26 | In distribution | |
| 332-0109 | Band Size 9 | In distribution | |
| 421-0104 | Width 427, Height 260 | 5 | In distribution |
| 421-0102 | Width 389, Height 240 | 5 | In distribution |
Showing 250 of 257 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Band, Preformed, Orthodontic | Forestadent Bernhard Förster GmbH | 8,646 |
| TruFit 2.0 | Ortho Technology, Inc. | 4,890 |
| TruFit™ | Ortho Organizers, Inc. | 3,943 |
| Leone SPA | Leone SPA | 2,549 |
| dentaform® | Dentaurum GmbH & Co. KG | 1,763 |
| Band Assemblies | Ortho Organizers, Inc. | 1,642 |
| 3M™ Victory Series™ | 3M Unitek | 1,388 |
| The Orthodontic Store | Young Innovations Inc. | 925 |
| Elite® Band Assemblies | Ortho Organizers, Inc. | 924 |
| TruFit™ 2.0 | Ortho Organizers, Inc. | 916 |
| 3M™ Unitek™ | 3M Unitek | 771 |
| Elite | Ortho Organizers, Inc. | 722 |
Showing 12 of 154. All products under Band, Preformed, 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.