Profin With IPR Lamineer Tips
Profin PDX Reciprocating Contra/Angle E-Type with 5x Assorted Inter-Proximal Reduction Lamineer Tips 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond…
Profin PDX Reciprocating Contra/Angle E-Type with 5x Assorted Inter-Proximal Reduction Lamineer Tips 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Who Else Makes It
Concentrated in Hebei (2), Henan (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Shofu Dental Material Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Dentatus AB, Sweden |
|---|---|
| FDA product code | EHL |
| Device type | Point, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PDX-P/SK2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 313 |
| Point, Abrasive | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 265 |
| Jazz Polisher | SS White Burs LLC | 128 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 125 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 122 |
| Komet Abrasive Instruments | Gebr. Brasseler Gmbh & Co. KG | 101 |
| Polishers | DFS-Diamon Gmbh | 101 |
| Dura-Green | Shofu Dental Corp. | 94 |
| Busch®, BNA® | Busch & Co. GmbH & Co. KG | 85 |
| MDT Dental Polishers | M.D.T. – Micro Diamond Technologies Ltd. | 81 |
| Henry Schein | Henry Schein, Inc. | 75 |
| Jota | Jota AG | 68 |
Showing 12 of 173. All products under Point, Abrasive
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.