ContacEZ
104 catalogue numbers from IPR PLUS Teal, listed by Directa AB, Sweden, under Strip, Polishing Agent. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
104catalogue 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 | Directa AB, Sweden |
|---|---|
| FDA product code | EHM |
| Device type | Strip, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPR PLUS Teal | In distribution | |
| IPR PLUS Clear | In distribution | |
| Restorative | In distribution | |
| Subgingival Small | In distribution | |
| Restorative White | In distribution | |
| IPR PLUS Turquoise | In distribution | |
| IPR PLUS Brown | In distribution | |
| Restorative Orange | In distribution | |
| IPR PLUS Assorted Medium | In distribution | |
| IPR Red | In distribution | |
| Hygienist Pink | In distribution | |
| Restorative Orange | In distribution | |
| LAB Black Medium | In distribution | |
| Veneer Finishing Kit | In distribution | |
| Restorative | In distribution | |
| Subgingival Gold Large | In distribution | |
| IPR Assorted Large | In distribution | |
| IPR Yellow | In distribution | |
| LAB Clear Small | In distribution | |
| Restorative Gray | In distribution | |
| Restorative Black | In distribution | |
| Restorative Gray | In distribution | |
| Restorative Black | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| Subgingival COPPER Small | In distribution | |
| IPR PLUS Brown | In distribution | |
| Hygienist Overhang Removal kit | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| IPR Strip System Intr | In distribution | |
| Signature Set | In distribution | |
| Restorative Blue | In distribution | |
| IPR PLUS Clear Medium | In distribution | |
| Restorative White | In distribution | |
| IPR Assorted Small | In distribution | |
| Subgingival Blue Large | In distribution | |
| Crown Seating Kit | In distribution | |
| IPR PLUS Aqua | In distribution | |
| IPR Rainbow Set (0.07 – 0.50) | In distribution | |
| IPR PLUS Aqua | In distribution | |
| Restorative Gray | In distribution | |
| IPR PLUS Cyan | In distribution | |
| Restorative Blue | In distribution | |
| IPR Combined (0.07mm – 0.30mm) | In distribution | |
| IPR Green | In distribution | |
| Restorative Black | In distribution | |
| Restorative White | In distribution | |
| LAB Assorted | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| IPR PLUS Cyan | In distribution | |
| Restorative | In distribution | |
| Restorative | In distribution | |
| Subgingival COPPER Medium | In distribution | |
| IPR PLUS Teal | In distribution | |
| LAB Clear Large | In distribution | |
| Subgingival Gold Medium | In distribution | |
| LAB Black Small | In distribution | |
| Restorative Blue | In distribution | |
| IPR Blue | In distribution | |
| IPR PLUS Teal | In distribution | |
| IPR PLUS Turquoise | In distribution | |
| IPR PLUS Mint | In distribution | |
| LAB Black Large | In distribution | |
| IPR PLUS Mint | In distribution | |
| IPR Green | In distribution | |
| IPR Combined (0.07mm – 0.30mm) | In distribution | |
| Hygienist Pink | In distribution | |
| Subgingival Gold Small | In distribution | |
| IPR PLUS Purple | In distribution | |
| Subgingival Blue Small | In distribution | |
| IPR PLUS Assorted Large | In distribution | |
| IPR 40/50 Promotional | In distribution | |
| IPR PLUS Purple | In distribution | |
| LAB Clear Medium | In distribution | |
| LAB Cyan | In distribution | |
| Restorative Orange | In distribution | |
| LAB Gray Large | In distribution | |
| Subgingival COPPER Large | In distribution | |
| IPR PLUS Turquoise | In distribution | |
| IPR PLUS Purple | In distribution | |
| IPR PLUS Clear | In distribution | |
| IPR PLUS Brown | In distribution | |
| LAB Gray Small | In distribution | |
| IPR Yellow | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| LAB Gray Medium | In distribution | |
| IPR PLUS Assorted Small | In distribution | |
| IPR Green | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| IPR PLUS Cyan | In distribution | |
| IPR PLUS Optional Assorted Kit | In distribution | |
| Subgingival Large | In distribution | |
| IPR Blue | In distribution | |
| IPR Assorted Medium | In distribution | |
| Composite Finishing Kit | In distribution | |
| IPR PLUS Mint | In distribution | |
| Subgingival Blue Medium | In distribution | |
| IPR Red | In distribution | |
| Hygienist Overhang Removal kit | In distribution | |
| Restorative | In distribution | |
| IPR Red | In distribution | |
| IPR Yellow | In distribution | |
| Hygienist Pink | In distribution | |
| IPR PLUS Aqua | In distribution | |
| IPR Blue | 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 95 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| Galaxy™ | Ortho Organizers, Inc. | 47 |
| NEW Metal Strips | GC America Inc. | 34 |
| 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.