Epic
Epic Etch Band L6L size 11
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 | 2025-08-22 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6E-U6R8-1 | In distribution | |
| 6E-L6R8-1 | In distribution | |
| 6E-L6L11-1 | In distribution | |
| 7E-L7R23-1 | In distribution | |
| 7E-L7R22-1 | In distribution | |
| 6E-L6R4-1 | In distribution | |
| 6E-U6L36-1 | In distribution | |
| 7E-L7R24-1 | In distribution | |
| 7E-L7R12-1 | In distribution | |
| 7E-U7L36-1 | In distribution | |
| 7E-L7L11-1 | In distribution | |
| 6E-L6L27-1 | In distribution | |
| 6E-U6R14-1 | In distribution | |
| 6E-L6R13-1 | In distribution | |
| 6E-L6R3-1 | In distribution | |
| 6E-L6L28-1 | In distribution | |
| 7E-U7R17-1 | In distribution | |
| 6E-L6R19-1 | In distribution | |
| 7E-L7L30-1 | In distribution | |
| 7E-U7R27-1 | In distribution | |
| 7E-U7L11-1 | In distribution | |
| 7E-U7L5-1 | In distribution | |
| 6E-L6L22-1 | In distribution | |
| 6E-U6L4-1 | In distribution | |
| 7E-U7R35-1 | In distribution | |
| 7E-U7R34-1 | In distribution | |
| 7E-L7L4-1 | In distribution | |
| 6E-U6L20-1 | In distribution | |
| 6E-U6R35-1 | In distribution | |
| 7E-L7R28-1 | In distribution | |
| 6E-L6L23-1 | In distribution | |
| 6E-L6L19-1 | In distribution | |
| 6E-L6L6-1 | In distribution | |
| 7E-L7R34-1 | In distribution | |
| 7E-L7L27-1 | In distribution | |
| 7E-L7L12-1 | In distribution | |
| 6E-L6R29-1 | In distribution | |
| 7E-U7R33-1 | In distribution | |
| 6E-U6L10-1 | In distribution | |
| 7E-U7R18-1 | In distribution | |
| 7E-L7R31-1 | In distribution | |
| 6E-L6R36-1 | In distribution | |
| 7E-U7L27-1 | In distribution | |
| 7E-L7L20-1 | In distribution | |
| 6E-U6L16-1 | In distribution | |
| 7E-L7L36-1 | In distribution | |
| 7E-U7L24-1 | In distribution | |
| 6E-L6L21-1 | In distribution | |
| 7E-U7R21-1 | In distribution | |
| 7E-U7R4-1 | In distribution | |
| 6E-L6R10-1 | In distribution | |
| 6E-U6R17-1 | In distribution | |
| 6E-L6R18-1 | In distribution | |
| 6E-L6L18-1 | In distribution | |
| 6E-L6L10-1 | In distribution | |
| 7E-L7L22-1 | In distribution | |
| 7E-U7L35-1 | In distribution | |
| 6E-U6L26-1 | In distribution | |
| 6E-L6L36-1 | In distribution | |
| 6E-U6R25-1 | In distribution | |
| 6E-U6R9-1 | In distribution | |
| 7E-U7R6-1 | In distribution | |
| 6E-U6R15-1 | In distribution | |
| 7E-L7R35-1 | In distribution | |
| 6E-U6R24-1 | In distribution | |
| 7E-L7R15-1 | In distribution | |
| 7E-L7R5-1 | In distribution | |
| 7E-L7L17-1 | In distribution | |
| 6E-L6L26-1 | In distribution | |
| 6E-U6R34-1 | In distribution | |
| 6E-L6L24-1 | In distribution | |
| 7E-L7L3-1 | In distribution | |
| 6E-L6L16-1 | In distribution | |
| 7E-U7R23-1 | In distribution | |
| 6E-U6L5-1 | In distribution | |
| 6E-L6R26-1 | In distribution | |
| 7E-U7R22-1 | In distribution | |
| 7E-L7R25-1 | In distribution | |
| 6E-U6L33-1 | In distribution | |
| 6E-U6L12-1 | In distribution | |
| 7E-L7L15-1 | In distribution | |
| 6E-L6L7-1 | In distribution | |
| 6E-U6R28-1 | In distribution | |
| 7E-L7R27-1 | In distribution | |
| 6E-U6L31-1 | In distribution | |
| 7E-L7R18-1 | In distribution | |
| 6E-U6R10-1 | In distribution | |
| 6E-L6L30-1 | In distribution | |
| 6E-L6L12-1 | In distribution | |
| 6E-U6R19-1 | In distribution | |
| 7E-L7L21-1 | In distribution | |
| 7E-L7L19-1 | In distribution | |
| 7E-U7R8-1 | In distribution | |
| 7E-L7L29-1 | In distribution | |
| 6E-U6R36-1 | In distribution | |
| 7E-U7L3-1 | In distribution | |
| 6E-U6R32-1 | In distribution | |
| 7E-U7R32-1 | In distribution | |
| 6E-U6R3-1 | In distribution | |
| 7E-L7R7-1 | In distribution | |
| 6E-U6L28-1 | In distribution | |
| 6E-U6R6-1 | In distribution | |
| 6E-L6R30-1 | In distribution | |
| 6E-U6R18-1 | In distribution | |
| 7E-U7L13-1 | In distribution | |
| 7E-U7R3-1 | In distribution | |
| 6E-U6L17-1 | In distribution | |
| 7E-L7L34-1 | In distribution | |
| 7E-L7R26-1 | In distribution | |
| 6E-L6R25-1 | In distribution | |
| 7E-U7R30-1 | In distribution | |
| 6E-U6R23-1 | In distribution | |
| 7E-U7L10-1 | In distribution | |
| 6E-U6L34-1 | In distribution | |
| 7E-U7R31-1 | In distribution | |
| 6E-L6R31-1 | In distribution | |
| 7E-L7R19-1 | In distribution | |
| 6E-L6R33-1 | In distribution | |
| 6E-U6R11-1 | In distribution | |
| 7E-L7R9-1 | In distribution | |
| 7E-L7R32-1 | In distribution | |
| 7E-U7L15-1 | In distribution | |
| 6E-U6R29-1 | In distribution | |
| 7E-L7L24-1 | In distribution | |
| 7E-U7R12-1 | In distribution | |
| 6E-L6R16-1 | In distribution | |
| 7E-U7L7-1 | In distribution | |
| 7E-L7R29-1 | In distribution | |
| 7E-U7L23-1 | In distribution | |
| 7E-U7L28-1 | In distribution | |
| 6E-U6R13-1 | In distribution | |
| 7E-U7R28-1 | In distribution | |
| 7E-U7L26-1 | In distribution | |
| 7E-L7L9-1 | In distribution | |
| 6E-U6L13-1 | In distribution | |
| 7E-L7R13-1 | In distribution | |
| 7E-U7R20-1 | In distribution | |
| 6E-L6R32-1 | In distribution | |
| 6E-L6L25-1 | In distribution | |
| 6E-L6R24-1 | In distribution | |
| 7E-U7L33-1 | In distribution | |
| 7E-U7L14-1 | In distribution | |
| 6E-U6L30-1 | In distribution | |
| 7E-U7L32-1 | In distribution | |
| 7E-U7R26-1 | In distribution | |
| 6E-L6R15-1 | In distribution | |
| 6E-L6R20-1 | In distribution | |
| 7E-L7R17-1 | In distribution | |
| 6E-U6R21-1 | In distribution | |
| 7E-L7R21-1 | In distribution | |
| 6E-L6L4-1 | In distribution | |
| 6E-L6R6-1 | In distribution | |
| 7E-L7R30-1 | In distribution | |
| 6E-L6R27-1 | In distribution | |
| 7E-L7R16-1 | In distribution | |
| 7E-U7R24-1 | In distribution | |
| 7E-U7L8-1 | In distribution | |
| 6E-L6L33-1 | In distribution | |
| 7E-U7L22-1 | In distribution | |
| 6E-L6L8-1 | In distribution | |
| 6E-U6R33-1 | In distribution | |
| 7E-L7L32-1 | In distribution | |
| 7E-U7L25-1 | In distribution | |
| 6E-L6L13-1 | In distribution | |
| 6E-L6R14-1 | In distribution | |
| 7E-L7L13-1 | In distribution | |
| 6E-L6L32-1 | In distribution | |
| 7E-U7L12-1 | In distribution | |
| 6E-L6R21-1 | In distribution | |
| 6E-U6L11-1 | In distribution | |
| 6E-L6R5-1 | In distribution | |
| 6E-L6L29-1 | In distribution | |
| 6E-U6L7-1 | In distribution | |
| 7E-L7L31-1 | In distribution | |
| 6E-U6L29-1 | In distribution | |
| 6E-U6L25-1 | In distribution | |
| 6E-L6L15-1 | In distribution | |
| 6E-U6L32-1 | In distribution | |
| 6E-L6R22-1 | In distribution | |
| 7E-U7L6-1 | In distribution | |
| 7E-U7R10-1 | In distribution | |
| 6E-U6L21-1 | In distribution | |
| 6E-U6R16-1 | In distribution | |
| 6E-U6L23-1 | In distribution | |
| 7E-L7R10-1 | In distribution | |
| 6E-U6L14-1 | In distribution | |
| 6E-L6L5-1 | In distribution | |
| 7E-U7R36-1 | In distribution | |
| 7E-L7L5-1 | In distribution | |
| 7E-L7L14-1 | In distribution | |
| 7E-L7R14-1 | In distribution | |
| 7E-U7R25-1 | In distribution | |
| 6E-U6R4-1 | In distribution | |
| 6E-U6R22-1 | In distribution | |
| 6E-L6R12-1 | In distribution | |
| 6E-U6L35-1 | In distribution | |
| 7E-U7R13-1 | In distribution | |
| 7E-L7L23-1 | In distribution | |
| 7E-U7R16-1 | In distribution | |
| 7E-U7L19-1 | In distribution | |
| 7E-U7R11-1 | In distribution | |
| 7E-L7R11-1 | In distribution | |
| 6E-L6R7-1 | In distribution | |
| 6E-U6L6-1 | In distribution | |
| 6E-U6R26-1 | In distribution | |
| 6E-L6R28-1 | In distribution | |
| 7E-L7R6-1 | In distribution | |
| 7E-U7L9-1 | In distribution | |
| 6E-L6L14-1 | In distribution | |
| 7E-U7L30-1 | In distribution | |
| 7E-U7R19-1 | In distribution | |
| 6E-U6L15-1 | In distribution | |
| 6E-U6R30-1 | In distribution | |
| 6E-U6R12-1 | In distribution | |
| 7E-L7L7-1 | In distribution | |
| 7E-U7L16-1 | In distribution | |
| 7E-U7L34-1 | In distribution | |
| 7E-L7L33-1 | In distribution | |
| 6E-U6R5-1 | In distribution | |
| 6E-L6R17-1 | In distribution | |
| 6E-L6L17-1 | In distribution | |
| 7E-U7L4-1 | In distribution | |
| 7E-L7R3-1 | In distribution | |
| 6E-L6L20-1 | In distribution | |
| 7E-U7L21-1 | In distribution | |
| 7E-L7L25-1 | In distribution | |
| 6E-U6L24-1 | In distribution | |
| 7E-L7L8-1 | In distribution | |
| 7E-U7R29-1 | In distribution | |
| 7E-U7L18-1 | In distribution | |
| 6E-L6L3-1 | In distribution | |
| 6E-L6L9-1 | In distribution | |
| 6E-L6R11-1 | In distribution | |
| 6E-U6R31-1 | In distribution | |
| 6E-L6R35-1 | In distribution | |
| 7E-L7R20-1 | In distribution | |
| 6E-L6R9-1 | In distribution | |
| 6E-U6R7-1 | In distribution | |
| 7E-L7R8-1 | In distribution | |
| 7E-L7L10-1 | In distribution | |
| 7E-L7R33-1 | In distribution | |
| 6E-U6L3-1 | In distribution | |
| 7E-L7L28-1 | In distribution | |
| 6E-U6R27-1 | In distribution | |
| 6E-L6R34-1 | In distribution | |
| 6E-U6L22-1 | In distribution | |
| 6E-L6R23-1 | In distribution | |
| 6E-U6L8-1 | In distribution | |
| 7E-U7R15-1 | In distribution | |
| 7E-U7L20-1 | In distribution |
Showing 250 of 272 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.