Tempra
Tempra Etch Band U7R size 42 1/2
27manufacturers in China registered for this device type
480catalogue 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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-08 |
| Record revised | 2025-12-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08E-UR6-330-3 | In distribution | |
| 08E-UR6-335-3 | In distribution | |
| 08E-UL6-440-3 | In distribution | |
| 09E-UL7-405-3 | In distribution | |
| 9E-U7R425-1 | In distribution | |
| 09E-LL7-360-3 | In distribution | |
| 09E-LR7-355-3 | In distribution | |
| 08E-UL6-355-3 | In distribution | |
| 9E-U7R335-1 | In distribution | |
| 8E-L6L30-1 | In distribution | |
| 8E-U6R295-1 | In distribution | |
| 09E-UL7-295-3 | In distribution | |
| 9E-U7L385-1 | In distribution | |
| 8E-L6L315-1 | In distribution | |
| 9E-L7L37-1 | In distribution | |
| 9E-L7L345-1 | In distribution | |
| 8E-L6L355-1 | In distribution | |
| 8E-U6R425-1 | In distribution | |
| 08E-UL6-420-3 | In distribution | |
| 9E-U7R35-1 | In distribution | |
| 9E-L7R36-1 | In distribution | |
| 9E-L7L405-1 | In distribution | |
| 08E-LL6-440-3 | In distribution | |
| 08E-UR6-325-3 | In distribution | |
| 08E-LR6-335-3 | In distribution | |
| 8E-L6L405-1 | In distribution | |
| 8E-U6R33-1 | In distribution | |
| 08E-LR6-430-3 | In distribution | |
| 9E-U7L355-1 | In distribution | |
| 09E-UL7-395-3 | In distribution | |
| 08E-UR6-415-3 | In distribution | |
| 09E-LR7-360-3 | In distribution | |
| 8E-U6L395-1 | In distribution | |
| 9E-L7R39-1 | In distribution | |
| 9E-L7R335-1 | In distribution | |
| 9E-L7R355-1 | In distribution | |
| 09E-LL7-440-3 | In distribution | |
| 8E-U6R32-1 | In distribution | |
| 9E-U7L315-1 | In distribution | |
| 09E-LR7-410-3 | In distribution | |
| 8E-L6R41-1 | In distribution | |
| 08E-LR6-400-3 | In distribution | |
| 9E-U7L42-1 | In distribution | |
| 8E-L6R30-1 | In distribution | |
| 08E-LL6-380-3 | In distribution | |
| 8E-L6R40-1 | In distribution | |
| 08E-UR6-345-3 | In distribution | |
| 09E-UL7-340-3 | In distribution | |
| 9E-L7R37-1 | In distribution | |
| 08E-LR6-315-3 | In distribution | |
| 08E-UL6-410-3 | In distribution | |
| 08E-LR6-410-3 | In distribution | |
| 9E-U7R435-1 | In distribution | |
| 9E-L7L39-1 | In distribution | |
| 8E-L6L425-1 | In distribution | |
| 9E-U7L39-1 | In distribution | |
| 8E-L6L44-1 | In distribution | |
| 8E-U6R31-1 | In distribution | |
| 9E-L7L36-1 | In distribution | |
| 9E-L7L355-1 | In distribution | |
| 09E-LL7-300-3 | In distribution | |
| 09E-UR7-295-3 | In distribution | |
| 9E-L7L435-1 | In distribution | |
| 9E-U7R405-1 | In distribution | |
| 9E-U7R305-1 | In distribution | |
| 9E-L7R375-1 | In distribution | |
| 09E-UR7-375-3 | In distribution | |
| 9E-U7R37-1 | In distribution | |
| 09E-UR7-415-3 | In distribution | |
| 08E-UR6-375-3 | In distribution | |
| 08E-LR6-310-3 | In distribution | |
| 09E-LR7-400-3 | In distribution | |
| 8E-U6R34-1 | In distribution | |
| 08E-UR6-425-3 | In distribution | |
| 9E-L7L365-1 | In distribution | |
| 09E-LR7-380-3 | In distribution | |
| 09E-LR7-345-3 | In distribution | |
| 9E-U7L425-1 | In distribution | |
| 09E-LR7-295-3 | In distribution | |
| 9E-L7R35-1 | In distribution | |
| 9E-U7R40-1 | In distribution | |
| 8E-L6L395-1 | In distribution | |
| 9E-U7L325-1 | In distribution | |
| 8E-U6R415-1 | In distribution | |
| 9E-L7R38-1 | In distribution | |
| 09E-LL7-415-3 | In distribution | |
| 09E-LL7-340-3 | In distribution | |
| 08E-LL6-395-3 | In distribution | |
| 09E-UR7-340-3 | In distribution | |
| 08E-LR6-395-3 | In distribution | |
| 09E-UR7-360-3 | In distribution | |
| 8E-U6R435-1 | In distribution | |
| 09E-LL7-385-3 | In distribution | |
| 9E-L7L34-1 | In distribution | |
| 08E-UL6-310-3 | In distribution | |
| 8E-L6R38-1 | In distribution | |
| 9E-L7R385-1 | In distribution | |
| 09E-LR7-310-3 | In distribution | |
| 08E-LR6-360-3 | In distribution | |
| 8E-L6R345-1 | In distribution | |
| 09E-LL7-380-3 | In distribution | |
| 9E-U7L435-1 | In distribution | |
| 9E-U7L335-1 | In distribution | |
| 8E-L6L32-1 | In distribution | |
| 8E-U6R315-1 | In distribution | |
| 09E-UL7-345-3 | In distribution | |
| 8E-L6R43-1 | In distribution | |
| 9E-L7R44-1 | In distribution | |
| 08E-UR6-410-3 | In distribution | |
| 09E-LR7-365-3 | In distribution | |
| 9E-U7R30-1 | In distribution | |
| 8E-U6L325-1 | In distribution | |
| 08E-LL6-335-3 | In distribution | |
| 8E-U6L305-1 | In distribution | |
| 8E-U6R39-1 | In distribution | |
| 08E-LR6-415-3 | In distribution | |
| 9E-U7L345-1 | In distribution | |
| 9E-L7R405-1 | In distribution | |
| 8E-L6L39-1 | In distribution | |
| 9E-U7L38-1 | In distribution | |
| 8E-L6R365-1 | In distribution | |
| 08E-UL6-415-3 | In distribution | |
| 08E-LL6-305-3 | In distribution | |
| 08E-UL6-430-3 | In distribution | |
| 8E-L6R36-1 | In distribution | |
| 09E-UL7-320-3 | In distribution | |
| 09E-UL7-335-3 | In distribution | |
| 8E-L6R39-1 | In distribution | |
| 08E-UR6-395-3 | In distribution | |
| 9E-L7L315-1 | In distribution | |
| 9E-U7R31-1 | In distribution | |
| 08E-LL6-365-3 | In distribution | |
| 08E-UL6-305-3 | In distribution | |
| 9E-U7R34-1 | In distribution | |
| 8E-L6R44-1 | In distribution | |
| 8E-L6R305-1 | In distribution | |
| 09E-LR7-300-3 | In distribution | |
| 8E-L6L40-1 | In distribution | |
| 08E-UL6-295-3 | In distribution | |
| 8E-U6L30-1 | In distribution | |
| 09E-UL7-350-3 | In distribution | |
| 9E-U7L415-1 | In distribution | |
| 8E-L6R295-1 | In distribution | |
| 8E-U6L375-1 | In distribution | |
| 09E-LR7-430-3 | In distribution | |
| 9E-U7R365-1 | In distribution | |
| 08E-LR6-370-3 | In distribution | |
| 8E-U6R37-1 | In distribution | |
| 08E-UR6-385-3 | In distribution | |
| 09E-UL7-390-3 | In distribution | |
| 9E-U7L43-1 | In distribution | |
| 08E-LL6-345-3 | In distribution | |
| 08E-LR6-405-3 | In distribution | |
| 9E-L7L42-1 | In distribution | |
| 08E-LR6-295-3 | In distribution | |
| 08E-LL6-385-3 | In distribution | |
| 9E-U7R36-1 | In distribution | |
| 09E-UL7-300-3 | In distribution | |
| 8E-L6L375-1 | In distribution | |
| 8E-L6R435-1 | In distribution | |
| 8E-U6R405-1 | In distribution | |
| 8E-L6R34-1 | In distribution | |
| 9E-L7L335-1 | In distribution | |
| 9E-L7L385-1 | In distribution | |
| 9E-U7R38-1 | In distribution | |
| 9E-L7R325-1 | In distribution | |
| 08E-LR6-385-3 | In distribution | |
| 8E-U6L35-1 | In distribution | |
| 9E-L7R315-1 | In distribution | |
| 8E-L6L35-1 | In distribution | |
| 8E-U6R345-1 | In distribution | |
| 09E-UL7-325-3 | In distribution | |
| 08E-UL6-405-3 | In distribution | |
| 8E-U6R41-1 | In distribution | |
| 08E-LL6-400-3 | In distribution | |
| 8E-L6L345-1 | In distribution | |
| 8E-U6L34-1 | In distribution | |
| 9E-L7L38-1 | In distribution | |
| 09E-UR7-320-3 | In distribution | |
| 08E-LR6-325-3 | In distribution | |
| 8E-L6L43-1 | In distribution | |
| 09E-LL7-320-3 | In distribution | |
| 09E-UR7-315-3 | In distribution | |
| 09E-UR7-395-3 | In distribution | |
| 8E-U6R305-1 | In distribution | |
| 9E-L7R365-1 | In distribution | |
| 09E-LR7-385-3 | In distribution | |
| 8E-L6R325-1 | In distribution | |
| 9E-L7L32-1 | In distribution | |
| 09E-LR7-395-3 | In distribution | |
| 08E-UL6-345-3 | In distribution | |
| 8E-U6L315-1 | In distribution | |
| 9E-L7L375-1 | In distribution | |
| 9E-U7R43-1 | In distribution | |
| 9E-U7L375-1 | In distribution | |
| 8E-U6R395-1 | In distribution | |
| 09E-LR7-335-3 | In distribution | |
| 8E-U6L44-1 | In distribution | |
| 09E-LR7-325-3 | In distribution | |
| 08E-LR6-355-3 | In distribution | |
| 8E-L6R335-1 | In distribution | |
| 09E-LR7-405-3 | In distribution | |
| 8E-L6R355-1 | In distribution | |
| 08E-LL6-370-3 | In distribution | |
| 9E-L7L40-1 | In distribution | |
| 08E-UR6-300-3 | In distribution | |
| 08E-UR6-320-3 | In distribution | |
| 9E-U7L395-1 | In distribution | |
| 08E-LL6-375-3 | In distribution | |
| 09E-LL7-400-3 | In distribution | |
| 09E-LL7-350-3 | In distribution | |
| 9E-L7R42-1 | In distribution | |
| 08E-UR6-390-3 | In distribution | |
| 9E-U7L365-1 | In distribution | |
| 08E-UR6-310-3 | In distribution | |
| 8E-U6L37-1 | In distribution | |
| 09E-UR7-430-3 | In distribution | |
| 9E-U7L35-1 | In distribution | |
| 09E-UR7-425-3 | In distribution | |
| 08E-UL6-325-3 | In distribution | |
| 09E-LR7-320-3 | In distribution | |
| 9E-U7L405-1 | In distribution | |
| 8E-U6L335-1 | In distribution | |
| 9E-L7R33-1 | In distribution | |
| 08E-LR6-425-3 | In distribution | |
| 08E-UL6-425-3 | In distribution | |
| 8E-U6L40-1 | In distribution | |
| 08E-UR6-440-3 | In distribution | |
| 09E-LR7-340-3 | In distribution | |
| 9E-L7L395-1 | In distribution | |
| 09E-LR7-390-3 | In distribution | |
| 09E-UL7-415-3 | In distribution | |
| 9E-L7L425-1 | In distribution | |
| 08E-LR6-350-3 | In distribution | |
| 09E-UR7-390-3 | In distribution | |
| 9E-U7L36-1 | In distribution | |
| 08E-UL6-385-3 | In distribution | |
| 08E-UL6-350-3 | In distribution | |
| 08E-LL6-355-3 | In distribution | |
| 9E-L7L41-1 | In distribution | |
| 08E-LL6-320-3 | In distribution | |
| 09E-LL7-370-3 | In distribution | |
| 08E-UL6-315-3 | In distribution | |
| 09E-UL7-410-3 | In distribution | |
| 08E-LR6-345-3 | In distribution | |
| 8E-U6L365-1 | In distribution | |
| 09E-LR7-425-3 | In distribution | |
| 09E-LR7-330-3 | In distribution | |
| 08E-UL6-435-3 | In distribution | |
| 08E-LL6-425-3 | In distribution |
Showing 250 of 300 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.