Plier, Orthodontic
Tweed loop forming pliers with individually replaceable hard metal tip, Premium-Line
28manufacturers in China registered for this device type
59catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (13), Shanghai (5), Guangdong (4). 4 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| 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 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
Showing 12 of 28. All 28 manufacturers in China registered for Plier, Orthodontic
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | JEX |
| Device type | Plier, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2025-12-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2025-12-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 045-003-00 | In distribution | ||
| 045-005-00 | In distribution | ||
| 012-351-00 | In distribution | ||
| 004-350-00 | In distribution | ||
| 012-350-00 | In distribution | ||
| 003-112-00 | In distribution | ||
| 003-710-00 | In distribution | ||
| 045-000-00 | In distribution | ||
| 045-004-00 | In distribution | ||
| 003-139-00 | In distribution | ||
| 039-357-00 | 10 | In distribution | |
| 045-001-00 | In distribution | ||
| 004-346-00 | In distribution | ||
| 003-001-00 | In distribution | ||
| 045-009-00 | In distribution | ||
| 003-349-00 | In distribution | ||
| 003-125-00 | In distribution | ||
| 003-120-00 | In distribution | ||
| 003-442-00 | In distribution | ||
| 023-293-00 | In distribution | ||
| 026-347-00 | In distribution | ||
| 003-805-00 | In distribution | ||
| 038-805-10 | 10 | In distribution | |
| 045-006-00 | In distribution | ||
| 004-109-00 | In distribution | ||
| 004-139-00 | In distribution | ||
| 004-130-00 | In distribution | ||
| 045-010-00 | In distribution | ||
| 004-347-00 | In distribution | ||
| 015-160-10 | In distribution | ||
| 003-205-00 | In distribution | ||
| 015-160-00 | In distribution | ||
| 003-185-00 | In distribution | ||
| 023-295-00 | In distribution | ||
| 003-711-00 | In distribution | ||
| 023-294-00 | In distribution | ||
| 003-130-00 | In distribution | ||
| 038-357-00 | 3 | In distribution | |
| 003-121-00 | In distribution | ||
| 003-180-01 | In distribution | ||
| 003-350-00 | In distribution | ||
| 045-002-00 | In distribution | ||
| 003-111-00 | In distribution | ||
| 003-114-00 | In distribution | ||
| 038-356-00 | 4 | In distribution | |
| 003-355-00 | In distribution | ||
| 023-288-00 | Withdrawn | ||
| 003-351-00 | Withdrawn | ||
| 023-291-00 | Withdrawn | ||
| 000-001-00 | Withdrawn | ||
| 023-290-00 | Withdrawn | ||
| 015-157-00 | Withdrawn | ||
| 004-349-00 | Withdrawn | ||
| 023-292-00 | Withdrawn | ||
| 038-805-00 | 10 | Withdrawn | |
| 001-002-00 | Withdrawn | ||
| 037-355-00 | 2 | Withdrawn | |
| 015-158-00 | Withdrawn | ||
| 023-289-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dentronix | Coltene/Whaledent Gmbh & Co. KG | 165 |
| Pomee | Pomee Corporation | 117 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 110 |
| Leone SPA | Leone SPA | 104 |
| Orthosource | Orthosource, Inc. | 103 |
| Power Dental USA | Power Dental U.S.A. Inc. | 103 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 102 |
| Henry Schein | Henry Schein, Inc. | 95 |
| American Eagle Instruments | American Eagle Instruments | 87 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 68 |
| Plier, Orthodontic | YDM Corporation | 67 |
| gSource | Gsource, LLC. | 64 |
Showing 12 of 219. All products under Plier, 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.