Komet Abrasive Instruments

101 catalogue numbers from DC9517F.314.030.A2, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, under Point, Abrasive. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26
9manufacturers in China registered for this device type
101catalogue 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.

Chinese manufacturers registered for FDA product code EHL
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

Regulatory record for Komet Abrasive Instruments
Listed by Gebr. Brasseler Gmbh & Co. KG, Germany
FDA product code EHL
Device type Point, Abrasive
Device class Class 1
Regulation 21 CFR 872.6010
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-02-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Komet Abrasive Instruments
Catalogue number Size Per pack Status
DC9517F.314.030.A2 5 In distribution
661.204.420.A4 10 In distribution
9608.204.030.A4 10 In distribution
94022F.204.060.A2 5 In distribution
9633.204.045.A4 10 In distribution
9661.000.030.A5 25 In distribution
9686.204.040.A2 5 In distribution
9616.204.060.A4 10 In distribution
94010C.204.040.A1 In distribution
94025F.204.070.A2 5 In distribution
9685.204.060.A2 5 In distribution
C9480.204.100.A2 5 In distribution
9646.000.020.A5 25 In distribution
9618.204.030.A1 In distribution
9618EF.204.030.A4 10 In distribution
94028M.204.130.A2 5 In distribution
9609.204.045.A4 10 In distribution
94000M.204.030.A2 5 In distribution
94022C.204.060.A1 In distribution
94000F.204.030.A2 5 In distribution
94020C.204.040.A2 5 In distribution
661.314.420.A4 10 In distribution
94012F.204.110.A2 5 In distribution
9664.204.055.A2 5 In distribution
C9479.204.050.A2 5 In distribution
9608.204.030.A1 In distribution
94004F.204.060.A1 In distribution
94005M.204.100.A2 5 In distribution
9618EF.204.030.A1 In distribution
94022F.204.060.A1 In distribution
9618.204.030.A4 10 In distribution
9616F.314.060.A4 10 In distribution
94010M.204.040.A2 5 In distribution
9648.000.020.A5 25 In distribution
94021F.204.050.A2 5 In distribution
94000C.204.030.A2 5 In distribution
9523UF.204.030.A2 5 In distribution
9676.204.100.A2 5 In distribution
9665.204.055.A2 5 In distribution
94020C.314.030.A1 In distribution
9606.204.060.A4 10 In distribution
94021F.204.050.A1 In distribution
9608.314.030.A6 100 In distribution
94026M.204.100.A2 5 In distribution
9606.204.060.A1 In distribution
9498.204.050.A4 10 In distribution
94006F.204.050.A2 5 In distribution
94005C.204.100.A2 5 In distribution
94010F.204.040.A1 In distribution
649.314.420.A4 10 In distribution
94010F.204.040.A2 5 In distribution
94000F.314.030.A2 5 In distribution
94023M.204.030.A2 5 In distribution
9499.204.060.A4 10 In distribution
9608.314.030.A4 10 In distribution
94020C.314.030.A2 5 In distribution
9608.314.030.A1 In distribution
94012F.204.110.A1 In distribution
9631.204.060.A4 10 In distribution
9618.204.030.A6 100 In distribution
94021C.204.050.A1 In distribution
94004M.204.060.A2 5 In distribution
94021C.204.050.A2 5 In distribution
C9478.204.060.A2 5 In distribution
C9481.314.030.A2 5 In distribution
94004C.204.060.A2 5 In distribution
94006C.204.050.A2 5 In distribution
94000C.314.030.A2 5 In distribution
94023F.204.030.A2 5 In distribution
9619.204.045.A4 10 In distribution
94010M.204.040.A1 In distribution
94005F.204.100.A2 5 In distribution
94000M.314.030.A2 5 In distribution
94012C.204.110.A1 In distribution
9618.314.030.A4 10 In distribution
9684.204.040.A2 5 In distribution
94025M.204.070.A2 5 In distribution
9677.204.100.A2 5 In distribution
94012C.204.110.A2 5 In distribution
9608.204.030.A6 100 In distribution
9606M.314.060.A4 10 In distribution
9618.314.030.A1 In distribution
645.314.420.A4 10 In distribution
94020F.204.040.A2 5 In distribution
601.204.420.A4 10 In distribution
DC9518F.204.040.A2 5 In distribution
601.314.420.A4 10 In distribution
94020F.314.030.A2 5 In distribution
94004F.204.060.A2 5 In distribution
94020C.204.040.A1 In distribution
9643.314.030.A6 100 In distribution
94028F.204.130.A2 5 In distribution
9525UF.204.085.A2 5 In distribution
94022C.204.060.A2 5 In distribution
DC9517M.314.030.A2 5 In distribution
9643.314.030.A4 10 In distribution
94006M.204.050.A2 5 In distribution
DC9518M.204.040.A2 5 In distribution
94010C.204.040.A2 5 In distribution
94026F.204.100.A2 5 In distribution
94020F.204.040.A1 In distribution

Same Product Code

Other products under the same FDA 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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer