Two Striper
Abrasive Point
9manufacturers in China registered for this device type
18catalogue numbers in this listing
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 | Abrasive Technology, LLC, United States |
|---|---|
| FDA product code | EHL |
| Device type | Point, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| STAINBUSTER 4002 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2503 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 4002 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 4001 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2506 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2540 TEN ASSTD 6-PACKS | 60 | In distribution | |
| STAINBUSTER 2501 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2505 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2502 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2504 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2502 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2506 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2504 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2501 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2505 TEN 6-BUR PACKS | 60 | In distribution | |
| STAINBUSTER 2540 ASST. 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 2503 6-BUR PACK | 6 | In distribution | |
| STAINBUSTER 4001 6-BUR PACK | 6 | 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.