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