Alpen
Alpen FG #699 Crosscut Tapered Fissure Carbide Burs 100/Pk
46manufacturers in China registered for this device type
1,243catalogue numbers in this listing
7recalls on this code
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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EJL |
| Device type | Bur, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2026-05-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Radiation Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2026-05-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60019103 | 100 | In distribution | |
| R600171 | 10 | In distribution | |
| R8605C012FG | 50 | In distribution | |
| X858F014 | 25 | In distribution | |
| X379F018 | 25 | In distribution | |
| R600034 | 10 | In distribution | |
| RS41557G | 10 | In distribution | |
| X859F014 | 25 | In distribution | |
| R41557GSS | 10 | In distribution | |
| X879KC014 | 25 | In distribution | |
| X85010M016 | 25 | In distribution | |
| RU100002 | 100 | In distribution | |
| R846C023FG | 50 | In distribution | |
| X10839M016 | 25 | In distribution | |
| X862C010 | 25 | In distribution | |
| R852F012FG | 50 | In distribution | |
| X856SC024S | 25 | In distribution | |
| RL100037 | 50 | In distribution | |
| X881SC014 | 25 | In distribution | |
| X805C016 | 25 | In distribution | |
| X813C014 | 25 | In distribution | |
| RS500008 | 10 | In distribution | |
| X859F012 | 25 | In distribution | |
| X885F012 | 25 | In distribution | |
| R707653 | 5 | In distribution | |
| RKS2SC014FG | 50 | In distribution | |
| RS100057 | 10 | In distribution | |
| RS100002 | 10 | In distribution | |
| R600005 | 10 | In distribution | |
| R877KSC016FG | 50 | In distribution | |
| X859EF014 | 25 | In distribution | |
| X863M012 | 25 | In distribution | |
| R837RF014FG | 50 | In distribution | |
| RS41558GB | 50 | In distribution | |
| R847C010FG | 50 | In distribution | |
| X379F023 | 25 | In distribution | |
| X858EF008 | 25 | In distribution | |
| X847SC014 | 25 | In distribution | |
| X859M014 | 25 | In distribution | |
| R500003 | 10 | In distribution | |
| RS100004 | 10 | In distribution | |
| R601158 | 10 | In distribution | |
| R707803 | 5 | In distribution | |
| RZ801F018FG | 5 | In distribution | |
| 60018591 | 10 | In distribution | |
| R707801 | 5 | In distribution | |
| X830M008 | 25 | In distribution | |
| RS200008 | 10 | In distribution | |
| R909714 | 5 | In distribution | |
| X847RM016 | 25 | In distribution | |
| R40701G | 10 | In distribution | |
| RS10169L | 10 | In distribution | |
| X848M016 | 25 | In distribution | |
| R852C016FG | 50 | In distribution | |
| R707408 | 5 | In distribution | |
| RL3001/2 | 50 | In distribution | |
| X847RSC018 | 25 | In distribution | |
| RS101558 | 10 | In distribution | |
| R500006 | 10 | In distribution | |
| X379SC023 | 25 | In distribution | |
| R707675 | 5 | In distribution | |
| R8567C016SS | 50 | In distribution | |
| R855F014FG | 50 | In distribution | |
| R909214 | 5 | In distribution | |
| R600703 | 10 | In distribution | |
| X837RF014 | 25 | In distribution | |
| R9EF6UF | 5 | In distribution | |
| RS100330 | 10 | In distribution | |
| R600700 | 10 | In distribution | |
| R856SC018FG | 50 | In distribution | |
| RKS1SC012FG | 50 | In distribution | |
| X856LF018 | 25 | In distribution | |
| R884F012FG | 50 | In distribution | |
| R849C016FG | 50 | In distribution | |
| R40245GSS | 10 | In distribution | |
| R7283-4 | 5 | In distribution | |
| X856TC014 | 25 | In distribution | |
| R856LSC021FG | 50 | In distribution | |
| R707572 | 5 | In distribution | |
| RS100558 | 10 | In distribution | |
| R90915F040FG | 5 | In distribution | |
| R878F012FG | 50 | In distribution | |
| RU100330 | 100 | In distribution | |
| X368EF023 | 25 | In distribution | |
| R9EF9UF | 5 | In distribution | |
| X850F014 | 25 | In distribution | |
| R600037 | 10 | In distribution | |
| R707108 | 5 | In distribution | |
| RS100008B | 50 | In distribution | |
| RKS3SC016FG | 50 | In distribution | |
| R100245C | 100 | In distribution | |
| R500171 | 10 | In distribution | |
| X858F008S | 25 | In distribution | |
| R707802 | 5 | In distribution | |
| RS500557 | 10 | In distribution | |
| R909903 | 5 | In distribution | |
| RL100057 | 50 | In distribution | |
| 60018643 | 10 | In distribution | |
| R707642 | 5 | In distribution | |
| RU300004 | 100 | In distribution | |
| R878KSC023FG | 50 | In distribution | |
| R707206 | 5 | In distribution | |
| R707102 | 5 | In distribution | |
| RS707408 | 10 | In distribution | |
| R835C010B | 50 | In distribution | |
| R500008 | 10 | In distribution | |
| RL100034 | 50 | In distribution | |
| R859C014FG | 50 | In distribution | |
| R811SC033FG | 5 | In distribution | |
| RS100037 | 10 | In distribution | |
| R500001 | 10 | In distribution | |
| R848F018FG | 50 | In distribution | |
| X878KF016 | 25 | In distribution | |
| R4152EZ | 5 | In distribution | |
| X878KC012 | 25 | In distribution | |
| R6331/2 | 10 | In distribution | |
| RS707714 | 10 | In distribution | |
| RS707406 | 10 | In distribution | |
| X801M018 | 25 | In distribution | |
| X856LSC018 | 25 | In distribution | |
| RS4152EZ | 10 | In distribution | |
| X858F008 | 25 | In distribution | |
| RS1001/2 | 10 | In distribution | |
| R40004GC | 10 | In distribution | |
| X859C014 | 25 | In distribution | |
| R859F018FG | 50 | In distribution | |
| R830C010SS | 50 | In distribution | |
| R41557G | 10 | In distribution | |
| X85010SC016 | 25 | In distribution | |
| R600057 | 10 | In distribution | |
| X878KSC018 | 25 | In distribution | |
| R700EF9 | 5 | In distribution | |
| X801C018 | 25 | In distribution | |
| RS707901 | 10 | In distribution | |
| R707106 | 5 | In distribution | |
| X909C042 | 25 | In distribution | |
| RS101557 | 10 | In distribution | |
| R801C023B | 50 | In distribution | |
| R500701 | 10 | In distribution | |
| R600169 | 10 | In distribution | |
| R834C016FG | 50 | In distribution | |
| RS100002B | 50 | In distribution | |
| R700EF4 | 5 | In distribution | |
| RU41558G | 100 | In distribution | |
| X801C016 | 25 | In distribution | |
| RR10330 | 10 | In distribution | |
| X856F018 | 25 | In distribution | |
| RS100330B | 50 | In distribution | |
| R501557 | 10 | In distribution | |
| R707104 | 5 | In distribution | |
| RL100002 | 50 | In distribution | |
| R707114 | 5 | In distribution | |
| X862F016 | 25 | In distribution | |
| RO100006 | 10 | In distribution | |
| RS500558 | 10 | In distribution | |
| RZ390F018FG | 5 | In distribution | |
| R836RC012SS | 50 | In distribution | |
| X863C012 | 25 | In distribution | |
| R40034G | 10 | In distribution | |
| R707713 | 5 | In distribution | |
| R600558 | 10 | In distribution | |
| R839C014FG | 50 | In distribution | |
| R909008 | 5 | In distribution | |
| RU300008 | 100 | In distribution | |
| RS100557B | 50 | In distribution | |
| X847RF016 | 25 | In distribution | |
| R601558 | 10 | In distribution | |
| R601702 | 10 | In distribution | |
| RS500701 | 10 | In distribution | |
| R40008G | 10 | In distribution | |
| R41558GSS | 10 | In distribution | |
| R707303 | 5 | In distribution | |
| RL100004 | 50 | In distribution | |
| X845RM025 | 25 | In distribution | |
| RS707611 | 10 | In distribution | |
| X858EF014 | 25 | In distribution | |
| R700EF6 | 5 | In distribution | |
| R600056 | 10 | In distribution | |
| X8567SC016 | 25 | In distribution | |
| RU300006 | 100 | In distribution | |
| R601171 | 10 | In distribution | |
| RS707214 | 10 | In distribution | |
| R707304 | 5 | In distribution | |
| X862F010 | 25 | In distribution | |
| R858C012SS | 50 | In distribution | |
| X859C012 | 25 | In distribution | |
| R909572 | 5 | In distribution | |
| RS100056 | 10 | In distribution | |
| R500703 | 10 | In distribution | |
| X847SC016 | 25 | In distribution | |
| RS101157 | 10 | In distribution | |
| X886C012 | 25 | In distribution | |
| X850C014 | 25 | In distribution | |
| RR4330G | 10 | In distribution | |
| RS2001/2 | 10 | In distribution | |
| X805M012 | 25 | In distribution | |
| R40037G | 10 | In distribution | |
| R5001/2 | 10 | In distribution | |
| RS300245 | 10 | In distribution | |
| 60019101 | 100 | In distribution | |
| X837RC014 | 25 | In distribution | |
| X879KSC018 | 25 | In distribution | |
| R905F023B | 50 | In distribution | |
| X878C014 | 25 | In distribution | |
| X856M014 | 25 | In distribution | |
| R100332C | 100 | In distribution | |
| X392M016 | 25 | In distribution | |
| X878KC021 | 25 | In distribution | |
| R707002 | 5 | In distribution | |
| RU100557 | 100 | In distribution | |
| R41558G | 10 | In distribution | |
| R845C012FG | 50 | In distribution | |
| RS100556B | 50 | In distribution | |
| R878F010FG | 50 | In distribution | |
| X368F020 | 25 | In distribution | |
| RS100331 | 10 | In distribution | |
| R856LF021FG | 50 | In distribution | |
| R601157 | 10 | In distribution | |
| R707404 | 5 | In distribution | |
| X856SC024 | 25 | In distribution | |
| R600003 | 10 | In distribution | |
| RU300002 | 100 | In distribution | |
| R9EF4UF | 5 | In distribution | |
| RS101158 | 10 | In distribution | |
| X881C009 | 25 | In distribution | |
| R707611 | 5 | In distribution | |
| X8568M016 | 25 | In distribution | |
| RCB8560188 | 5 | In distribution | |
| R806C014FG | 50 | In distribution | |
| R9EF3UF | 5 | In distribution | |
| R600004 | 10 | In distribution | |
| R6001/2 | 10 | In distribution | |
| X837C016 | 25 | In distribution | |
| X856TC016 | 25 | In distribution | |
| R40002G | 10 | In distribution | |
| X811SC033 | 25 | In distribution | |
| R500557 | 10 | In distribution | |
| RS100245 | 10 | In distribution | |
| RS707406B | 50 | In distribution | |
| X10839M014 | 25 | In distribution | |
| R40702G | 10 | In distribution | |
| R600035 | 10 | In distribution | |
| R707714 | 5 | In distribution | |
| X878C012 | 25 | In distribution | |
| XU8568SC016 | 100 | In distribution | |
| R848LC018FG | 50 | In distribution | |
| R862EF016FG | 50 | In distribution | |
| X801F023 | 25 | In distribution | |
| R877KC014B | 50 | In distribution | |
| R40557GC | 100 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 423 |
Showing 12 of 2,159. All products under Bur, Dental
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-10-20 | Class II | Under Investigation by firm | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | 556 packs | |
| 2020-10-20 | Class II | Under Investigation by firm | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | 556 | |
| 2020-10-20 | Class II | Under Investigation by firm | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | 556 | |
| 2020-10-20 | Class II | Under Investigation by firm | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | 556 | |
| 2020-10-20 | Class II | Under Investigation by firm | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | 556 | |
| 2019-07-19 | Class II | Error in labeling | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. | 20 units of 5 burs/unit | 2021-04-30 |
| 2018-04-13 | Class II | Under Investigation by firm | The products are labeled with an incorrect product number. | 11 | 2019-04-08 |
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.