Busch®, BNA®

2-step diamond interspersed polishing system for ceramics/silicate ceramics - pre-polishing, red yellow

Registry build 21.09.26
9manufacturers in China registered for this device type
85catalogue 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 Busch®, BNA®
Listed by Busch & Co. GmbH & Co. KG, Germany
FDA product code EHL
Device type Point, Abrasive
Device class Class 1
Regulation 21 CFR 872.6010
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2025-12-15

Specifications

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

Catalogue Numbers

Catalogue numbers for Busch®, BNA®
Catalogue number Size Per pack Status
9818 030 CERA POL DIA F 2 In distribution
661 030 GRUEN SIL-CARB RA 6 In distribution
661 030 ARKAN CORUNDUM FG 6 In distribution
649 025 ARKAN CORUNDUM RA 6 In distribution
9579 040 COMP POL DIA F 2 In distribution
637 025 GRUEN SIL-CARB RA 6 In distribution
9907 030 WST ZIRK POL DIA 2 In distribution
9609 050 METAL POL M 6 In distribution
601 030 GRUEN SIL-CARB RA 6 In distribution
9817 060 CERA POL DIA F 2 In distribution
9617 065 METAL POL FINE 6 In distribution
619 050 GRUEN SIL-CARB RA 6 In distribution
9635 060 NYLON SOFT 50 In distribution
9918 030 ZIRC POL DIA F 2 In distribution
9679 050 COMP POL FINE 6 In distribution
9635S 060 RA NYL S-SOFT 50 In distribution
9633S 070 PROPHY SOFT 50 In distribution
9609G 050 UNIV POL COARS 6 In distribution
9587 060 COMP POL DIA M 2 In distribution
661 030 ARKAN CORUNDUM RA 6 In distribution
9593 055 COMP POL DIA F 2 In distribution
9731SIC 040 SIC-BRUSH M 6 In distribution
9583 055 COMP POL DIA M 2 In distribution
626 050 GRUEN SIL-CARB RA 6 In distribution
9809 040 CERA POL DIA M 2 In distribution
9619 050 METAL POL FINE 6 In distribution
667 040 GRUEN SIL-CARB RA 6 In distribution
9731S 040 RA NYL S-SOFT 50 In distribution
601 030 ARKAN CORUNDUM FG 6 In distribution
9607G 070 UNIV POL COARS 6 In distribution
9667 070 COMP POL M 6 In distribution
9588 030 COMP POL DIA M 2 In distribution
666 033 GRUEN SIL-CARB RA 6 In distribution
9919 040 ZIRC POL DIA F 2 In distribution
9608G 030 UNIV POL COARS 6 In distribution
9581 140 COMP POL DIA F 2 In distribution
9808 030 CERA POL DIA M 2 In distribution
9650 050 RA POL ADHESI 2 In distribution
9608 030 METAL POL M 6 In distribution
9635H 060 PROPHY SOFT 50 In distribution
9589 040 COMP POL DIA M 2 In distribution
9730H 040 RA NYL HARD 50 In distribution
653 030 ARKAN CORUNDUM RA 6 In distribution
601 030 ARKAN CORUNDUM RA 6 In distribution
662 035 GRUEN SIL-CARB RA 6 In distribution
9677 070 COMP POL FINE 6 In distribution
9730SIC 040 SIC-BRUSH M 6 In distribution
9607 065 METAL POL M 6 In distribution
9819 040 CERA POL DIA F 2 In distribution
9731 040 RA NYL SOFT 50 In distribution
9730S 040 RA NYL S-SOFT 50 In distribution
9921 140 ZIRC POL DIA F 2 In distribution
602 040 GRUEN SIL-CARB RA 6 In distribution
9618 030 METAL POL FINE 6 In distribution
9917 060 ZIRC POL DIA F 2 In distribution
9621 140 METAL POL FINE 3 In distribution
9669 050 COMP POL M 6 In distribution
9821 140 CERA POL DIA F 2 In distribution
9591 140 COMP POL DIA M 2 In distribution
9608 030 METAL M FG 6 In distribution
9618 030 METAL FINE FG 6 In distribution
9611 140 METAL POL M 3 In distribution
9807 060 CERA POL DIA M 2 In distribution
9811 140 CERA POL DIA M 2 In distribution
671 050 GRUEN SIL-CARB RA 6 In distribution
9577 060 COMP POL DIA F 2 In distribution
603 050 GRUEN SIL-CARB RA 6 In distribution
9578 030 COMP DIA F FG 2 In distribution
622 060 GRUEN SIL-CARB RA 6 In distribution
9731H 040 RA NYL HARD 50 In distribution
9909 040 ZIRC POL DIA M 2 In distribution
9668 030 COMP POL M 6 In distribution
9588 030 COMP DIA M FG 2 In distribution
9678 030 COMP POL FINE 6 In distribution
9578 030 COMP POL DIA F 2 In distribution
9908 030 WST ZIRK POL DIA M 2 In distribution
648 020 GRUEN SIL-CARB RA 6 In distribution
649 025 ARKAN CORUNDUM FG 6 In distribution
9730 040 RA NYL SOFT 50 In distribution
649 025 GRUEN SIL-CARB RA 6 In distribution
9735SIC 060 SIC-BRUSH M 6 In distribution
9650 030 RA POL ADHESI 2 In distribution
9911 140 ZIRC POL DIA M 2 In distribution
627 060 GRUEN SIL-CARB RA 6 In distribution
653 030 ARKAN CORUNDUM FG 6 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
Komet Abrasive Instruments Gebr. Brasseler Gmbh & Co. KG 101
Polishers DFS-Diamon Gmbh 101
Dura-Green Shofu Dental Corp. 94
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