MARK3

Blue Streak Diamond Burs Gross Reduction Cylinder Short 652.017 Extra Coarse Black - MARK3®

Registry build 21.09.26
46manufacturers in China registered for this device type
135catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (12), Shanghai (8), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJL
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai MU Promotions Co., Ltd. Shanghai Shanghai Exporter 62
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51

Showing 12 of 46. All 46 manufacturers in China registered for Bur, Dental

Record

Regulatory record for MARK3
Listed by Cargus International, Inc
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Premarket notification Exempt
Record published 2023-08-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MARK3
Catalogue number Size Status
886-012C In distribution
847-016C In distribution
856L-016C In distribution
856-025C In distribution
856-018XC In distribution
858-014XF In distribution
801-012C In distribution
848-012C In distribution
881-014C In distribution
878K-018C In distribution
836-014C In distribution
837-014C In distribution
850-016F In distribution
862-012M In distribution
859-010M In distribution
801-016C In distribution
862-010F In distribution
878-014C In distribution
805-016C In distribution
837-014M In distribution
859-016C In distribution
885-012M In distribution
863-012F In distribution
862-014XF In distribution
837-016M In distribution
878-012C In distribution
847-018C In distribution
886-012M In distribution
855-017XF In distribution
368-023XC In distribution
856-016M In distribution
655S-018XC In distribution
909-040C In distribution
837-012M In distribution
801-018C In distribution
885-012C In distribution
855-018C In distribution
855-017F In distribution
801-016M In distribution
863-012M In distribution
858-014M In distribution
858-014C In distribution
807-018M In distribution
856-012C In distribution
379-023F In distribution
379-023M In distribution
878-012M In distribution
847KR-016C In distribution
856-018F In distribution
856L-018C In distribution
878K-014C In distribution
856-016XC In distribution
850-014C In distribution
862-010C In distribution
801-014C In distribution
855-016C In distribution
850-018C In distribution
859-014C In distribution
848-016C In distribution
835-010M In distribution
886-016C In distribution
850-012C In distribution
801-012M In distribution
859-016F In distribution
863-012C In distribution
801-018F In distribution
392-016F In distribution
835-016C In distribution
835-012C In distribution
848-018XC In distribution
847-014C In distribution
850-016C In distribution
856-016F In distribution
858-016M In distribution
878K-016C In distribution
863-018C In distribution
837-018XC In distribution
845KR-026M In distribution
855-018XC In distribution
855-016XC In distribution
835-010C In distribution
652S-017XC In distribution
862-012XF In distribution
859-012C In distribution
368-023C In distribution
845KR-026F In distribution
379-018F In distribution
847KR-016M In distribution
811-037C In distribution
652S-018XC In distribution
368-016C In distribution
855-012F In distribution
805-012C In distribution
368-016M In distribution
392-016XF In distribution
856-014C In distribution
848-016M In distribution
837-012C In distribution
863-014C In distribution
856-018C In distribution
811-033C In distribution
801-014M In distribution
801-018M In distribution
368-023F In distribution
847-010C In distribution
379-023XF In distribution
859-010F In distribution
855-012M In distribution
847-016M In distribution
379-023C In distribution
845-KR-026C In distribution
856-016C In distribution
855-018C In distribution
859-014F In distribution
807-016M In distribution
846KR-016M In distribution
368-023M In distribution
847KR-017C In distribution
837-016C In distribution
859-014XF In distribution
862-014C In distribution
855-012C In distribution
862-012F In distribution
862-012C In distribution
848-018C In distribution
368-016F In distribution
855-016M In distribution
830L-012M In distribution
811-037XC In distribution
368-023XF In distribution
859-016XF In distribution
862-014F In distribution
379-018M In distribution
836-012C In distribution
845KR-019C In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MDT Tungsten Carbide Dental Burs M.D.T. – Micro Diamond Technologies Ltd. 1,795
Brasseler USA Peter Brasseler Holdings, LLC 1,719
Bur, Dental Hager & Meisinger Gesellschaft mit beschränkter Haftung 1,458
Edenta Edenta Etablissement 1,415
Alpen Coltene/Whaledent Gmbh & Co. KG 1,243
Komet Dental Tungsten Carbide Burs Gebr. Brasseler Gmbh & Co. KG 760
Henry Schein Henry Schein, Inc. 665
House Brand Dentistry Frontier Dental Supply Inc 659
SSW Carbide SS White Burs LLC 610
Sabur By 3D Dental 3D Dental Designs AND Development, LLC 530
Beyes Beyes Dental Canada, Inc. 509
Johnson-Promident Young Innovations Inc. 439

Showing 12 of 2,159. All products under Bur, Dental

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