NEW Metal Strips
NEW METAL STRIPS Assortment "A" Package, #200 Mesh Extra Coarse (four A, four B and four C widths) Red
18manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Llrn Personal Care (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 20 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Showing 12 of 18. All 18 manufacturers in China registered for Strip, Polishing Agent
Record
| Listed by | GC America Inc., United States |
|---|---|
| FDA product code | EHM |
| Device type | Strip, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-05 |
| Record revised | 2018-04-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000267 | In distribution | |
| 000261 | In distribution | |
| 000258 | In distribution | |
| 000263 | In distribution | |
| 000254 | In distribution | |
| 000256 | In distribution | |
| 000252 | In distribution | |
| 000254 | In distribution | |
| 000264 | In distribution | |
| 000251 | In distribution | |
| 000258 | In distribution | |
| 000259 | In distribution | |
| 000257 | In distribution | |
| 000262 | In distribution | |
| 000255 | In distribution | |
| 000260 | In distribution | |
| 000252 | In distribution | |
| 000265 | In distribution | |
| 000266 | In distribution | |
| 000251 | In distribution | |
| 000260 | In distribution | |
| 000259 | In distribution | |
| 000263 | In distribution | |
| 000262 | In distribution | |
| 000256 | In distribution | |
| 000265 | In distribution | |
| 000266 | In distribution | |
| 000264 | In distribution | |
| 000253 | In distribution | |
| 000267 | In distribution | |
| 000253 | In distribution | |
| 000257 | In distribution | |
| 000261 | In distribution | |
| 000255 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 197 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 146 |
| MDT Diamond Coated Dental Flexible Strips | M.D.T. – Micro Diamond Technologies Ltd. | 121 |
| ContacEZ | Directa AB | 104 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 95 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| Galaxy™ | Ortho Organizers, Inc. | 47 |
| SpaceFile® | Dentsply Sirona Orthodontics Inc. | 29 |
| Microdont | 3R – Industria E Comercio Eireli | 28 |
| Two Striper | Abrasive Technology, LLC | 21 |
| Denfinity | 3R – Industria E Comercio Eireli | 21 |
| Prodia | Abrasive Technology, LLC | 19 |
Showing 12 of 83. All products under Strip, Polishing Agent
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.