Henry Schein
Maxima Safety Hold Replacement Silicone Insert
28manufacturers in China registered for this device type
95catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | JEX |
| Device type | Plier, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9007666 | In distribution | ||
| 9007612 | In distribution | ||
| 9007631 | In distribution | ||
| 1064800 | In distribution | ||
| 1127222 | In distribution | ||
| 1127212 | In distribution | ||
| 9007619 | In distribution | ||
| 9007611 | In distribution | ||
| 9007625 | In distribution | ||
| 1003929 | In distribution | ||
| 1004871 | In distribution | ||
| 9007623 | In distribution | ||
| 1127216 | In distribution | ||
| 1000841 | In distribution | ||
| 9007616 | In distribution | ||
| 1061778 | In distribution | ||
| 1127221 | In distribution | ||
| 9007599 | In distribution | ||
| 9007602 | In distribution | ||
| 1001277 | In distribution | ||
| 1067249 | In distribution | ||
| 1062301 | In distribution | ||
| 1003141 | In distribution | ||
| 1008222 | In distribution | ||
| 1127224 | In distribution | ||
| 1005275 | In distribution | ||
| 9007604 | In distribution | ||
| 1062209 | In distribution | ||
| 9007634 | In distribution | ||
| 9007630 | In distribution | ||
| 1005357 | In distribution | ||
| 9007624 | In distribution | ||
| 1127209 | In distribution | ||
| 9007669 | 6 | In distribution | |
| 1127206 | In distribution | ||
| 1127205 | In distribution | ||
| 1127214 | In distribution | ||
| 1127208 | In distribution | ||
| 9007632 | In distribution | ||
| 1004126 | In distribution | ||
| 9007667 | 6 | In distribution | |
| 9007615 | In distribution | ||
| 1127228 | In distribution | ||
| 1127203 | In distribution | ||
| 1003065 | In distribution | ||
| 9007601 | In distribution | ||
| 1127225 | In distribution | ||
| 1008740 | In distribution | ||
| 9007622 | In distribution | ||
| 9007606 | In distribution | ||
| 1001147 | In distribution | ||
| 1068552 | In distribution | ||
| 1005921 | In distribution | ||
| 9007603 | In distribution | ||
| 1004559 | In distribution | ||
| 1127213 | In distribution | ||
| 9007600 | In distribution | ||
| 1007712 | In distribution | ||
| 9007629 | In distribution | ||
| 1127204 | In distribution | ||
| 1001358 | In distribution | ||
| 9007626 | In distribution | ||
| 1000815 | In distribution | ||
| 1127215 | In distribution | ||
| 1127219 | In distribution | ||
| 9007608 | In distribution | ||
| 9007620 | In distribution | ||
| 9007670 | 3 | In distribution | |
| 9007621 | In distribution | ||
| 1067415 | In distribution | ||
| 1001655 | In distribution | ||
| 1127226 | In distribution | ||
| 1004859 | In distribution | ||
| 9007617 | In distribution | ||
| 9007613 | In distribution | ||
| 1002258 | In distribution | ||
| 9007607 | In distribution | ||
| 1127218 | In distribution | ||
| 9007635 | In distribution | ||
| 1008005 | In distribution | ||
| 1127217 | In distribution | ||
| 1005511 | In distribution | ||
| 9007609 | In distribution | ||
| 1127227 | In distribution | ||
| 1127202 | In distribution | ||
| 9007628 | In distribution | ||
| 9007627 | In distribution | ||
| 9007605 | In distribution | ||
| 1127211 | In distribution | ||
| 1008966 | In distribution | ||
| 9007633 | In distribution | ||
| 9007614 | In distribution | ||
| 9007610 | In distribution | ||
| 1127210 | In distribution | ||
| 9007618 | In distribution |
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 |
| American Eagle Instruments | American Eagle Instruments | 87 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 68 |
| Plier, Orthodontic | YDM Corporation | 67 |
| gSource | Gsource, LLC. | 64 |
| Plier, Orthodontic | Dentaurum GmbH & Co. KG | 59 |
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.