Luno
Instrument Luno Replacement Tips, Screw AND Wrench FOR 001-017405
28manufacturers in China registered for this device type
38catalogue 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 | American Orthodontics, United States |
|---|---|
| FDA product code | JEX |
| Device type | Plier, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-07 |
| Record revised | 2022-10-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001-023353 | In distribution | |
| 001-037659 | In distribution | |
| 001-017391 | In distribution | |
| 001-017386 | In distribution | |
| 001-017388 | In distribution | |
| 001-037660 | In distribution | |
| 001-017405 | In distribution | |
| 001-023349 | In distribution | |
| 001-017403 | In distribution | |
| 001-017381 | In distribution | |
| 001-023350 | In distribution | |
| 001-017394 | In distribution | |
| 001-017382 | In distribution | |
| 001-017397 | In distribution | |
| 001-017393 | In distribution | |
| 001-017387 | In distribution | |
| 001-017396 | In distribution | |
| 001-017383 | In distribution | |
| 001-023354 | In distribution | |
| 001-017390 | In distribution | |
| 001-017385 | In distribution | |
| 001-023351 | In distribution | |
| 001-017380 | In distribution | |
| 001-017384 | In distribution | |
| 001-036566 | In distribution | |
| 001-017406 | In distribution | |
| 001-017392 | In distribution | |
| 001-017395 | In distribution | |
| 001-017407 | In distribution | |
| 001-017398 | In distribution | |
| 001-017389 | In distribution | |
| 001-017402 | Withdrawn | |
| 001-017402 | Withdrawn | |
| 001-025385 | Withdrawn | |
| 001-025385 | Withdrawn | |
| 001-023352 | Withdrawn | |
| 001-023355 | Withdrawn | |
| 001-017404 | 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.