Point, Abrasive
Intraoral Twist Polisher Kit for Hybrid Ceramics Intraoral Polishing Kit, according to Greg Campbell, DDS
9manufacturers in China registered for this device type
265catalogue 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 | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | EHL |
| Device type | Point, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Premarket notification | Exempt |
| Record published | 2021-09-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DCA15 100 | 2 | In distribution | |
| 9502H 043 | 5 | In distribution | |
| DPO07 060 | 2 | In distribution | |
| 649XF 025 | 5 | In distribution | |
| 9980V 060 | 5 | In distribution | |
| D9782 080 | 5 | In distribution | |
| 9553U 030 | In distribution | ||
| 667 035 | 5 | In distribution | |
| 645F 028 | 5 | In distribution | |
| 9749G 110 | 2 | In distribution | |
| 9771C 100 | 2 | In distribution | |
| 9781 060 | 5 | In distribution | |
| 9745M 056 | 2 | In distribution | |
| 117 040 | 10 | In distribution | |
| 9991F 030 | 5 | In distribution | |
| 601XF 030 | 5 | In distribution | |
| 649 025 | 5 | In distribution | |
| 666 025 | 5 | In distribution | |
| D9781 057 | 5 | In distribution | |
| PTP0T | In distribution | ||
| 9734H 040 | 2 | In distribution | |
| 9528V 065 | 5 | In distribution | |
| SF1RF | 2 | In distribution | |
| 9771F 140 | 2 | In distribution | |
| 9503V 033 | 5 | In distribution | |
| 9534P 055 | 100 | In distribution | |
| DCA16 100 | 2 | In distribution | |
| 9718M 100 | 2 | In distribution | |
| 9652V 045 | 5 | In distribution | |
| 9768M 060 | 2 | In distribution | |
| 9569V 055 | 5 | In distribution | |
| 9995C 065 | 5 | In distribution | |
| 9741F 030 | 2 | In distribution | |
| 9653H 070 | 5 | In distribution | |
| PST02 | In distribution | ||
| 9767F 030 | 2 | In distribution | |
| 661 025 | 5 | In distribution | |
| PCL09 030 | 5 | In distribution | |
| DPP04 | 2 | In distribution | |
| 9741M 030 | 2 | In distribution | |
| 9983V 045 | 5 | In distribution | |
| 9981P 030 | 5 | In distribution | |
| 9995 060 | 5 | In distribution | |
| 9713F 033 | 2 | In distribution | |
| 9526V 047 | 5 | In distribution | |
| 9981P 030 | 5 | In distribution | |
| LUS04 | In distribution | ||
| 629XF 023 | 5 | In distribution | |
| 660XF 025 | 5 | In distribution | |
| 118 060 | 10 | In distribution | |
| PTP01 | In distribution | ||
| 9517P 140 | 2 | In distribution | |
| 9782 100 | 5 | In distribution | |
| 9536P 060 | 10 | In distribution | |
| PTP0T | In distribution | ||
| GC02 | In distribution | ||
| 9754F 055 | 50 | In distribution | |
| 9771G 140 | 2 | In distribution | |
| Z662 035 | 2 | In distribution | |
| 9996 060 | 5 | In distribution | |
| 627 060 | 5 | In distribution | |
| 9528P 065 | 5 | In distribution | |
| JK01 | In distribution | ||
| 601XF 030 | 5 | In distribution | |
| 9503H 033 | 5 | In distribution | |
| 9760F 100 | 2 | In distribution | |
| 9744G 060 | 2 | In distribution | |
| PCL08 023 | 5 | In distribution | |
| DCA04 040 | 2 | In distribution | |
| DCA14 060 | 2 | In distribution | |
| 9537P 100 | 10 | In distribution | |
| 9744M 060 | 2 | In distribution | |
| 9714F 060 | 2 | In distribution | |
| ACE23 | In distribution | ||
| 9531P 030 | 100 | In distribution | |
| 651 032 | 5 | In distribution | |
| 661XF 025 | 5 | In distribution | |
| 9744C 060 | 2 | In distribution | |
| 9757F 110 | 50 | In distribution | |
| 9760M 100 | 2 | In distribution | |
| 603 050 | 5 | In distribution | |
| D9780 041 | 5 | In distribution | |
| 662XF 030 | 5 | In distribution | |
| 9569P 055 | 5 | In distribution | |
| 9714M 060 | 2 | In distribution | |
| 9741M 030 | 2 | In distribution | |
| 601F 030 | 5 | In distribution | |
| 9503H 033 | 5 | In distribution | |
| 9981H 030 | 5 | In distribution | |
| 9771F 100 | 2 | In distribution | |
| 650 028 | 5 | In distribution | |
| 9504U 090 | 5 | In distribution | |
| 9571P 065 | 5 | In distribution | |
| 661XF 025 | 5 | In distribution | |
| PCL07 033 | 5 | In distribution | |
| 9714G 060 | 2 | In distribution | |
| 9743C 040 | 2 | In distribution | |
| 9517V 140 | 2 | In distribution | |
| DCA13 060 | 2 | In distribution | |
| 9653V 070 | 5 | In distribution | |
| 9981H 030 | 5 | In distribution | |
| 612XF 055 | 5 | In distribution | |
| DPO02 040 | 2 | In distribution | |
| 9734G 040 | 2 | In distribution | |
| DPP03 | 2 | In distribution | |
| 9504H 065 | 5 | In distribution | |
| 645F 028 | 5 | In distribution | |
| 9742F 040 | 2 | In distribution | |
| 9744F 060 | 2 | In distribution | |
| 9995M 070 | 5 | In distribution | |
| 9746G 100 | 2 | In distribution | |
| 9535P 030 | 10 | In distribution | |
| 9546P 055 | 5 | In distribution | |
| 9652P 045 | 5 | In distribution | |
| 9508U 110 | 5 | In distribution | |
| 638XF 025 | 5 | In distribution | |
| 9746F 100 | 2 | In distribution | |
| 9755F 040 | 50 | In distribution | |
| PCL04 030 | 5 | In distribution | |
| 2662 | In distribution | ||
| GBK23 | In distribution | ||
| 612XF 055 | 5 | In distribution | |
| 9506V 050 | 5 | In distribution | |
| 601 030 | 5 | In distribution | |
| 660XF 025 | 5 | In distribution | |
| 9765F 055 | 2 | In distribution | |
| 639 035 | 5 | In distribution | |
| 666XF 025 | 5 | In distribution | |
| 9756M 060 | 50 | In distribution | |
| 9502V 043 | 5 | In distribution | |
| PPKS1 | In distribution | ||
| 9532P 060 | 100 | In distribution | |
| DCA10 040 | 2 | In distribution | |
| 666 025 | 5 | In distribution | |
| CPK01 | In distribution | ||
| 9529P 100 | 2 | In distribution | |
| PCL03 023 | 5 | In distribution | |
| PST01 | In distribution | ||
| PHA02 070 | In distribution | ||
| 9718F 100 | 2 | In distribution | |
| 617XF 023 | 5 | In distribution | |
| 9517H 140 | 2 | In distribution | |
| GC06 | In distribution | ||
| 9749M 110 | 2 | In distribution | |
| PCL02 033 | 5 | In distribution | |
| 619XF 023 | 5 | In distribution | |
| 9785 030 | 5 | In distribution | |
| 9577P 080 | 5 | In distribution | |
| 9988V 160 | 5 | In distribution | |
| 9571V 065 | 5 | In distribution | |
| 9713M 033 | 2 | In distribution | |
| 9504U 070 | 5 | In distribution | |
| LUS06 | In distribution | ||
| DPO05 040 | 2 | In distribution | |
| 9754M 055 | 50 | In distribution | |
| 9503V 033 | 5 | In distribution | |
| COSI1 | In distribution | ||
| 9579P 100 | 5 | In distribution | |
| 9579H 100 | 5 | In distribution | |
| 9983P 045 | 5 | In distribution | |
| 649 025 | 5 | In distribution | |
| SR02 | In distribution | ||
| 661F 025 | 5 | In distribution | |
| 9745F 057 | 2 | In distribution | |
| 9502P 043 | 5 | In distribution | |
| ELE01 | In distribution | ||
| 9712M 040 | 2 | In distribution | |
| 9756F 060 | 50 | In distribution | |
| 9765M 055 | 2 | In distribution | |
| LUS30 | In distribution | ||
| 2605 | In distribution | ||
| 9502U 045 | 5 | In distribution | |
| 9741G 030 | 2 | In distribution | |
| PCL05 030 | 5 | In distribution | |
| 2663 | In distribution | ||
| 649F 025 | 5 | In distribution | |
| 9780 040 | 5 | In distribution | |
| 9746M 100 | 2 | In distribution | |
| 629XF 023 | 5 | In distribution | |
| 9527V 033 | 5 | In distribution | |
| 9766F 050 | 2 | In distribution | |
| 671 060 | 5 | In distribution | |
| 9653P 070 | 5 | In distribution | |
| 9527P 033 | 5 | In distribution | |
| 9769F 140 | 2 | In distribution | |
| 9741F 030 | 2 | In distribution | |
| DPP02 | 2 | In distribution | |
| 9767F 030 | 2 | In distribution | |
| 9981V 030 | 5 | In distribution | |
| 9718G 100 | 2 | In distribution | |
| 9762F 040 | 2 | In distribution | |
| 9503P 033 | 5 | In distribution | |
| PCL10 030 | 5 | In distribution | |
| 638F 025 | 5 | In distribution | |
| 9767M 030 | 2 | In distribution | |
| PSO03 070 | In distribution | ||
| 9743F 040 | 2 | In distribution | |
| 9569H 055 | 5 | In distribution | |
| 9981V 030 | 5 | In distribution | |
| 9579V 100 | 5 | In distribution | |
| 9980H 060 | 5 | In distribution | |
| 661F 025 | 5 | In distribution | |
| 9533P 100 | 100 | In distribution | |
| 9983H 045 | 5 | In distribution | |
| 9553P 030 | In distribution | ||
| 661 025 | 5 | In distribution | |
| 9771M 140 | 2 | In distribution | |
| 622 065 | 5 | In distribution | |
| 649XF 025 | 5 | In distribution | |
| 9743M 040 | 2 | In distribution | |
| 9745G 055 | 2 | In distribution | |
| 9746C 100 | 2 | In distribution | |
| 9577V 080 | 5 | In distribution | |
| 9769M 140 | 2 | In distribution | |
| 602 040 | 5 | In distribution | |
| DPO08 060 | 2 | In distribution | |
| DPP01 | 2 | In distribution | |
| 9503U 030 | 5 | In distribution | |
| ACO23 | In distribution | ||
| 617XF 023 | 5 | In distribution | |
| 9755M 040 | 50 | In distribution | |
| 9526P 047 | 5 | In distribution | |
| 662 035 | 5 | In distribution | |
| 9771C 140 | 2 | In distribution | |
| 9757M 110 | 50 | In distribution | |
| 9768F 060 | 2 | In distribution | |
| 2664 | In distribution | ||
| LUS02 | In distribution | ||
| 119 040 | 10 | In distribution | |
| 638XF 025 | 5 | In distribution | |
| PCL01 023 | 5 | In distribution | |
| 9980P 060 | 5 | In distribution | |
| 665 060 | 5 | In distribution | |
| PCL06 023 | 5 | In distribution | |
| 9712G 040 | 2 | In distribution | |
| 9771M 100 | 2 | In distribution | |
| 9743G 040 | 2 | In distribution | |
| 9769F 100 | 2 | In distribution | |
| 9504P 065 | 5 | In distribution | |
| GC04 | In distribution | ||
| 9991C 030 | 5 | In distribution | |
| 9501U 055 | 5 | In distribution | |
| 613 070 | 5 | In distribution | |
| 9652H 045 | 5 | In distribution | |
| PSS04 070 | In distribution | ||
| 9766M 050 | 2 | In distribution | |
| 619XF 023 | 5 | In distribution | |
| 9769M 100 | 2 | In distribution | |
| 9767M 030 | 2 | In distribution | |
| 9762M 040 | 2 | In distribution |
Showing 250 of 265 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 313 |
| 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 |
| Johnson-Promident | Young Innovations Inc. | 37 |
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.