Ortho Arch
Lite 1/4' Ligature Remover/ Director ***discontinued/ While Supplies Last. NON-Refundable OR Returnable***
10manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 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 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Zhejiang Shinye Medical Technology Corp.,Ltd | Hangzhou | Zhejiang | Manufacturer | 10 |
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Ortho Arch Company Inc, United States |
|---|---|
| FDA product code | ECP |
| Device type | Instrument, Ligature Tucking, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-09-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800-106 | In distribution | |
| 800-065X | In distribution | |
| 800-028 | In distribution | |
| 800-076 | In distribution | |
| 800-077 | In distribution | |
| 800-117 | In distribution | |
| 700-601 | In distribution | |
| 800-120 | In distribution | |
| 800-031 | In distribution | |
| 800-070 | In distribution | |
| 700-604 | In distribution | |
| 800-510 | In distribution | |
| 700-613 | In distribution | |
| 700-602 | In distribution | |
| 800-126 | In distribution | |
| 800-046 | In distribution | |
| 800-041 | In distribution | |
| 700-605 | In distribution | |
| 700-603 | In distribution | |
| 700-600 | In distribution | |
| 800-027 | In distribution | |
| 700-606 | In distribution | |
| 800-121 | In distribution | |
| 800-045 | In distribution | |
| 800-030 | In distribution | |
| 700-617 | In distribution | |
| 800-064X | In distribution | |
| 800-118 | In distribution | |
| 700-611 | In distribution | |
| 800-032 | In distribution | |
| 800-039L | In distribution | |
| 800-136 | In distribution | |
| 800-511 | In distribution | |
| 700-609 | In distribution | |
| 700-610 | In distribution | |
| 800-133 | In distribution | |
| 800-122 | In distribution | |
| 800-119 | In distribution | |
| 800-018 | In distribution | |
| 800-040 | In distribution | |
| 700-612 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 76 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 36 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 19 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 11 |
| Leone SPA | Leone SPA | 10 |
| Power Dental USA | Power Dental U.S.A. Inc. | 9 |
| Spectrum | Ortho Arch Company Inc | 9 |
| J & J Instruments | J & J Instruments, LLC | 8 |
| General Instruments | American Orthodontics | 8 |
| Quinelato | Schobell Industrial Ltda | 8 |
| Preformed Ligature Wire | Ortho Arch Company Inc | 6 |
| Director | KLS-Martin L.P. | 6 |
Showing 12 of 89. All products under Instrument, Ligature Tucking, 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.