Alpen Carbides

Alpen Carbides 1557G-FGSS-1.00-4.10, 10 pcs

Registry build 21.09.26
46manufacturers in China registered for this device type
212catalogue 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 Alpen Carbides
Listed by DENT4YOU AG, Switzerland
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2024-09-13

Specifications

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

Catalogue Numbers

Catalogue numbers for Alpen Carbides
Catalogue number Size Per pack Status
R1001/2C 100 In distribution
R100006 10 In distribution
R41558GC 100 In distribution
R100701 10 In distribution
R707664 5 In distribution
R707006 5 In distribution
R101170 10 In distribution
RCB8470148 5 In distribution
R707901 5 In distribution
60024011 100 In distribution
R40002G 10 In distribution
R100035 10 In distribution
R40245GC 100 In distribution
R100005 10 In distribution
R40557G 10 In distribution
R500002 10 In distribution
R707903 5 In distribution
R100034C 100 In distribution
R100256C 100 In distribution
R100556C 100 In distribution
R41557GSS 10 In distribution
R41557G 10 In distribution
R100557 10 In distribution
R100004 10 In distribution
R707406 5 In distribution
R5001/2 10 In distribution
R100008 10 In distribution
R40004G 10 In distribution
R100256 10 In distribution
R101169 10 In distribution
R100557C 100 In distribution
R909006 5 In distribution
R300557 10 In distribution
R707675 5 In distribution
R100246C 100 In distribution
R7283K6 5 In distribution
R700EF9 5 In distribution
R100003C 100 In distribution
R10170L 10 In distribution
R100169 10 In distribution
RCB8560128 5 In distribution
R100034 10 In distribution
R40245GSS 10 In distribution
R100331C 100 In distribution
R100330 10 In distribution
R2001/2 10 In distribution
R200006 10 In distribution
R9EF6UF 5 In distribution
R100702C 100 In distribution
R500702 10 In distribution
R200004C 100 In distribution
R101556 10 In distribution
R100056C 100 In distribution
R707408 5 In distribution
R100057C 100 In distribution
R101558 10 In distribution
R300008 10 In distribution
R41557GC 100 In distribution
R500001 10 In distribution
R707802 5 In distribution
R40034G 10 In distribution
R501158 10 In distribution
R300330C 100 In distribution
RCB8560148 5 In distribution
R40245G 10 In distribution
R100035C 100 In distribution
R41558G 10 In distribution
R40556G 10 In distribution
R200008C 100 In distribution
R909404 5 In distribution
R100558 10 In distribution
R1331/2C 100 In distribution
R909406 5 In distribution
R100700C 100 In distribution
R707106 5 In distribution
R100006C 100 In distribution
R100700 10 In distribution
R100245C 100 In distribution
R10169LC 100 In distribution
R100001 10 In distribution
R500004 10 In distribution
R707801 5 In distribution
R300006 10 In distribution
R101171 10 In distribution
R301156 10 In distribution
R500003 10 In distribution
R200006C 100 In distribution
R300002 10 In distribution
R100957 10 In distribution
R40004GC 100 In distribution
R500703 10 In distribution
RCB8560168 5 In distribution
R100169C 100 In distribution
R40557GSS 10 In distribution
R707803 5 In distribution
R40330GSS 10 In distribution
R100036C 100 In distribution
R100330C 100 In distribution
R707009 5 In distribution
R4152EZ 5 In distribution
R100246 10 In distribution
R100008C 100 In distribution
R1001/2 10 In distribution
RCB8470128 5 In distribution
R100701C 100 In distribution
R101171C 100 In distribution
R100329 10 In distribution
R707214 5 In distribution
R10701L 10 In distribution
R200002 10 In distribution
R707404 5 In distribution
R101156 10 In distribution
R40199Z 5 In distribution
R500006 10 In distribution
R500557 10 In distribution
R707611 5 In distribution
R100170 10 In distribution
R707102 5 In distribution
R300245 10 In distribution
R100332 10 In distribution
R300556 10 In distribution
R707008 5 In distribution
R100331 10 In distribution
R707902 5 In distribution
R101157 10 In distribution
R40035G 10 In distribution
R909408 5 In distribution
R500557C 100 In distribution
R1001/4 10 In distribution
R100558C 100 In distribution
R100245 10 In distribution
R10169L 10 In distribution
R501558 10 In distribution
R2001/4 10 In distribution
R100007 10 In distribution
R100003 10 In distribution
R100004C 100 In distribution
R40557GC 100 In distribution
R300004 10 In distribution
R9EF9UF 5 In distribution
R909803 5 In distribution
R40702G 10 In distribution
R200003 10 In distribution
R40330G 10 In distribution
R100001C 100 In distribution
RCB8470168 5 In distribution
R100057 10 In distribution
R40331GC 100 In distribution
R501557 10 In distribution
R707714 5 In distribution
R40008G 10 In distribution
R4219EZ 5 In distribution
R500701 10 In distribution
R707204 5 In distribution
R101169C 100 In distribution
R707104 5 In distribution
R100005C 100 In distribution
R200004 10 In distribution
R200007 10 In distribution
R300331 10 In distribution
R40701G 10 In distribution
R40558G 10 In distribution
R100699C 100 In distribution
R101157C 100 In distribution
RCB379023 5 In distribution
R300330 10 In distribution
R101557 10 In distribution
R100056 10 In distribution
R100036 10 In distribution
R100037C 100 In distribution
R500558 10 In distribution
R10700L 10 In distribution
R101557C 100 In distribution
R40006G 10 In distribution
R100002C 100 In distribution
R500008 10 In distribution
R100170C 100 In distribution
R3001/4 10 In distribution
R40331G 10 In distribution
R200005 10 In distribution
R300557C 100 In distribution
R200001 10 In distribution
R100257 10 In distribution
R909008 5 In distribution
R200008 10 In distribution
R700EF4 5 In distribution
R700EF6 5 In distribution
R909903 5 In distribution
R101156C 100 In distribution
R100702 10 In distribution
R100007C 100 In distribution
R1001/4C 100 In distribution
R700EF3 5 In distribution
R100956 10 In distribution
R40330GC 100 In distribution
R100556 10 In distribution
R707103 5 In distribution
R100332C 100 In distribution
R707612 5 In distribution
R100329C 100 In distribution
R101558C 100 In distribution
R10702L 10 In distribution
R100002 10 In distribution
R100699 10 In distribution
R707642 5 In distribution
R500556 10 In distribution
R100257C 100 In distribution
R5001/4 10 In distribution
R40151Z 5 In distribution
R100037 10 In distribution
R1331/2 10 In distribution
R301157 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