ACE

BUR Taper Dome #1703L 59MM 2.1HD 7CL Step Notch STL 10/PK Shank #5

Registry build 21.09.26
46manufacturers in China registered for this device type
113catalogue 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 ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Premarket notification Exempt
Record published 2019-10-13
Record revised 2020-06-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required
Sizes Outer diameter 0.3 to 6 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Per pack Status
92250018 Outer Diameter 1.8 mm 10 In distribution
63501703 Outer Diameter 2.1 mm 10 In distribution
00310028 Outer Diameter 2.8 mm In distribution
61651902 Outer Diameter 2.1 mm 10 In distribution
20440180 Outer Diameter 4.5 mm In distribution
10350166 Outer Diameter 2 mm In distribution
64501703 Outer Diameter 2.1 mm 10 In distribution
11380001 Outer Diameter 2 mm In distribution
90440018 Outer Diameter 4 mm In distribution
90700045 Outer Diameter 1.5 mm In distribution
64441703ST Outer Diameter 2.1 mm 10 In distribution
61500002 Outer Diameter 2.1 mm 10 In distribution
88330010 Outer Diameter 5 mm In distribution
90440018ST Outer Diameter 2.3 mm In distribution
31500023ST Outer Diameter 5.5 mm In distribution
12440001S Outer Diameter 0.3 mm In distribution
64441703 Outer Diameter 2.1 mm 10 In distribution
80700012 Outer Diameter 2.1 mm In distribution
31590031ST Outer Diameter 5.5 mm In distribution
31580031 Outer Diameter 5.5 mm In distribution
68250003 Outer Diameter 1.6 mm 10 In distribution
62591702ST Outer Diameter 1.6 mm 10 In distribution
00500013 Outer Diameter 6 mm In distribution
90500018S Outer Diameter 1.8 mm In distribution
61500003 Outer Diameter 1.6 mm 10 In distribution
63591703ST Outer Diameter 2.1 mm 10 In distribution
00500060 Outer Diameter 6 mm In distribution
63441703 Outer Diameter 1.6 mm 10 In distribution
61501902 Outer Diameter 2.1 mm 10 In distribution
31500023S Outer Diameter 5.5 mm In distribution
62441702 Outer Diameter 2.1 mm 10 In distribution
61651909 Outer Diameter 1.6 mm 10 In distribution
90500023 Outer Diameter 2.3 mm In distribution
63441903ST Outer Diameter 2.1 mm 10 In distribution
90440023S Outer Diameter 1.8 mm In distribution
61440002S Outer Diameter 4 mm 10 In distribution
10650168S Outer Diameter 2.3 mm In distribution
64651903 Outer Diameter 2.1 mm 10 In distribution
64591703ST Outer Diameter 2.1 mm 10 In distribution
04941202 In distribution
68250002 Outer Diameter 1.2 mm 10 In distribution
62441702ST Outer Diameter 1.6 mm 10 In distribution
31500023 Outer Diameter 4 mm In distribution
90440023 Outer Diameter 1.8 mm In distribution
00450028S Outer Diameter 2.8 mm In distribution
31440023 Outer Diameter 5.5 mm In distribution
00500014 Outer Diameter 6 mm In distribution
10600168 Outer Diameter 2 mm In distribution
11470001 Outer Diameter 2 mm In distribution
00350028 Outer Diameter 2.8 mm In distribution
00450028 Outer Diameter 2.8 mm In distribution
31440020S Outer Diameter 2.3 mm In distribution
90250018 Outer Diameter 4.5 mm 10 In distribution
90700100 Outer Diameter 2.5 mm In distribution
31310024 Outer Diameter 1.8 mm In distribution
10650168 Outer Diameter 2.3 mm In distribution
31310023 Outer Diameter 0.8 mm In distribution
31680031 Outer Diameter 5.5 mm In distribution
62651902 Outer Diameter 1.6 mm 10 In distribution
10440166S Outer Diameter 2 mm In distribution
00500015 Outer Diameter 4 mm In distribution
64651703 Outer Diameter 2.1 mm 10 In distribution
90250023 Outer Diameter 2.35 mm 10 In distribution
62591902ST Outer Diameter 1.6 mm 10 In distribution
63441903 Outer Diameter 1.6 mm 10 In distribution
11380001 Outer Diameter 2 mm In distribution
00450028ST Outer Diameter 2.8 mm In distribution
63591903ST Outer Diameter 2.1 mm 10 In distribution
80730013 Outer Diameter 2.1 mm In distribution
31440023ST Outer Diameter 4 mm In distribution
31680031ST Outer Diameter 4 mm In distribution
64591903ST Outer Diameter 2.1 mm 10 In distribution
90500023S Outer Diameter 2.3 mm In distribution
90440023ST Outer Diameter 1.8 mm In distribution
62501902 Outer Diameter 1.6 mm 10 In distribution
64501903 Outer Diameter 2.1 mm 10 In distribution
90500100 Outer Diameter 2.5 mm In distribution
61501909 Outer Diameter 1.6 mm 10 In distribution
10440164S Outer Diameter 1.8 mm In distribution
31680031S Outer Diameter 4 mm In distribution
62441902 Outer Diameter 2.1 mm 10 In distribution
31440020ST Outer Diameter 4 mm In distribution
90440018S Outer Diameter 1.8 mm In distribution
62651702 Outer Diameter 1.6 mm 10 In distribution
64441903 Outer Diameter 2.1 mm 10 In distribution
62441902ST Outer Diameter 1.6 mm 10 In distribution
61650002 Outer Diameter 2.1 mm 10 In distribution
10650168ST Outer Diameter 2.3 mm In distribution
63501903 Outer Diameter 2.1 mm 10 In distribution
61650003 Outer Diameter 1.6 mm 10 In distribution
90600200 Outer Diameter 5 mm In distribution
61441902 Outer Diameter 1.6 mm 10 In distribution
63651703 Outer Diameter 2.1 mm 10 In distribution
90700220 Outer Diameter 6 mm In distribution
62501702 Outer Diameter 1.6 mm 10 In distribution
61440003S Outer Diameter 5.5 mm 10 In distribution
90500018 Outer Diameter 1.8 mm In distribution
10440164 Outer Diameter 1.8 mm In distribution
64441903ST Outer Diameter 2.1 mm 10 In distribution
63651903 Outer Diameter 2.1 mm 10 In distribution
31750021S Outer Diameter 4 mm In distribution
10440166 Outer Diameter 2 mm In distribution
10800169 Outer Diameter 2.3 mm In distribution
00500035 Outer Diameter 3.5 mm In distribution
19260162 Outer Diameter 1.6 mm In distribution
63441703ST Outer Diameter 1.6 mm 10 In distribution
61440003 Outer Diameter 4 mm 10 In distribution
21650110S Outer Diameter 1.8 mm In distribution
11470001 Outer Diameter 2 mm In distribution
61441909 Outer Diameter 2.1 mm 10 In distribution
21650110 Outer Diameter 2.3 mm In distribution
88330009 Outer Diameter 2.1 mm In distribution
92250023 Outer Diameter 2.3 mm 10 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