Denfinity

FG Diamond Burs 653.018C Coarse Cylindrical Rounded with Triangular Rings STERILE PK/25

Registry build 21.09.26
46manufacturers in China registered for this device type
274catalogue 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 Denfinity
Listed by 3R – Industria E Comercio Eireli
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Premarket notification Exempt
Record published 2026-03-10

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
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Denfinity
Catalogue number Size Per pack Status
41.099.1/4 10 In distribution
10.155.2134C 10 In distribution
41.099.8 10 In distribution
10.155.4113C 10 In distribution
41.098.558 10 In distribution
41.098.7901F 10 In distribution
10.154.3169 In distribution
10.155.2068C 10 In distribution
10.155.3168BHLF 10 In distribution
41.098.OS556 10 In distribution
10.155.1015 10 In distribution
10.154.1148C In distribution
41.099.OS4 10 In distribution
10.155.1092C 10 In distribution
41.098.702 10 In distribution
10.155.4112C 10 In distribution
10.154.2134C In distribution
10.154.4120F In distribution
10.155.2135C 10 In distribution
10.154.3169C In distribution
41.098.9714FF 10 In distribution
41.098.9406FF 10 In distribution
41.100.002 10 In distribution
41.098.57SS 10 In distribution
41.098.1156 10 In distribution
10.154.3229SC In distribution
41.098.4SS 10 In distribution
41.098.7404F 10 In distribution
10.154.1093 In distribution
41.098.557SS 10 In distribution
10.154.2134F In distribution
41.098.170L 10 In distribution
41.098.7664F 10 In distribution
41.098.2SS 10 In distribution
41.098.7206F 10 In distribution
10.155.2202EF 10 In distribution
10.154.4108C In distribution
41.098.170 10 In distribution
10.154.4136C In distribution
41.100.007 10 In distribution
41.099.1 10 In distribution
10.155.2136C 10 In distribution
41.098.OS4 10 In distribution
10.155.3139C 10 In distribution
41.098.OS558 10 In distribution
10.155.3038HLC 10 In distribution
10.154.4137F In distribution
41.098.245SS 10 In distribution
10.154.1016VC In distribution
10.154.3170F In distribution
10.154.3169F In distribution
10.154.3185HLC In distribution
10.154.1015VC In distribution
10.155.4135C 10 In distribution
41.099.OS2 10 In distribution
10.154.1018C In distribution
10.154.1192F In distribution
41.098.7006F 10 In distribution
10.154.2127C In distribution
10.154.2126C In distribution
41.098.9008FF 10 In distribution
41.098.9103FF 10 In distribution
41.098.245 10 In distribution
41.098.558SS 10 In distribution
10.154.2068C In distribution
10.155.3199C 10 In distribution
10.155.3118EF 10 In distribution
41.098.9904FF 10 In distribution
10.154.2136C In distribution
10.154.4120C In distribution
10.155.3069C 10 In distribution
41.098.7214F 10 In distribution
41.098.9006FF 10 In distribution
41.099.35 10 In distribution
10.154.3229SF In distribution
10.154.3191F In distribution
10.155.3168EF 10 In distribution
41.098.7714F 10 In distribution
10.155.2138C 10 In distribution
10.154.3185HLVC In distribution
10.155.2067C 10 In distribution
10.155.3145C 10 In distribution
41.098.556 10 In distribution
41.098.1/4 10 In distribution
41.098.9903FF 10 In distribution
10.154.3171F In distribution
41.098.7114F 10 In distribution
41.098.9642FF 10 In distribution
41.098.169 10 In distribution
10.154.3171 In distribution
10.154.3039VC In distribution
41.099.2 10 In distribution
41.101.704 10 In distribution
10.155.4112F 10 In distribution
41.099.34 10 In distribution
10.155.3117C 10 In distribution
10.154.3171C In distribution
41.098.7803F 10 In distribution
41.098.1171 10 In distribution
41.100.005 10 In distribution
10.154.2135VC In distribution
41.098.7802F 10 In distribution
41.098.330SS 10 In distribution
41.098.557L 10 In distribution
10.155.3168VC 10 In distribution
41.098.3 10 In distribution
41.098.56SS 10 In distribution
41.098.170SS 10 In distribution
10.154.1092C In distribution
10.154.3170EF In distribution
41.098.701L 10 In distribution
41.098.257 10 In distribution
41.098.331/2 10 In distribution
10.155.1035C 10 In distribution
41.098.1157 10 In distribution
41.099.5 10 In distribution
41.098.557 10 In distribution
10.154.3038C In distribution
10.155.2135VC 10 In distribution
10.155.3195EF 10 In distribution
10.155.2068LMC 10 In distribution
10.155.3071 10 In distribution
10.154.1014C In distribution
41.100.003 10 In distribution
41.098.7408F 10 In distribution
41.098.7801F 10 In distribution
10.154.3235F In distribution
10.154.1092 In distribution
41.098.331/2SS 10 In distribution
10.154.1143 In distribution
10.154.3096C In distribution
10.155.3194F 10 In distribution
10.154.4136VC In distribution
41.098.37 10 In distribution
10.155.4112EF 10 In distribution
41.099.331/2 10 In distribution
10.155.2135HLVC 10 In distribution
10.154.4137VC In distribution
41.098.7902F 10 In distribution
10.154.3118F In distribution
41.098.1171L 10 In distribution
41.099.1/2 10 In distribution
41.101.153 10 In distribution
10.154.3039C In distribution
41.098.7903F 10 In distribution
10.154.3169VC In distribution
41.100.006 10 In distribution
10.154.1018VC In distribution
41.098.OS1557 10 In distribution
10.155.3069LMC 10 In distribution
41.098.OS557 10 In distribution
10.154.3038F In distribution
10.154.2126 In distribution
10.155.3168F 10 In distribution
10.154.3068VC In distribution
41.098.1557 10 In distribution
41.098.9803FF 10 In distribution
41.098.169L 10 In distribution
10.154.3053 In distribution
10.155.1012C 10 In distribution
41.098.171 10 In distribution
10.154.1016C In distribution
10.154.2096C In distribution
10.154.4138C In distribution
41.098.556SS 10 In distribution
10.154.1013C In distribution
10.154.4136C In distribution
41.098.OS2 10 In distribution
10.155.4136C 10 In distribution
10.155.4116C 10 In distribution
41.099.4 10 In distribution
41.098.7406F 10 In distribution
41.098.331 10 In distribution
41.098.7104F 10 In distribution
41.098.329 10 In distribution
41.098.700 10 In distribution
10.154.1378 In distribution
41.098.701SS 10 In distribution
10.155.3216C 10 In distribution
41.098.34 10 In distribution
41.099.OS8 10 In distribution
41.099.37 10 In distribution
10.155.3146C 10 In distribution
41.098.OS6 10 In distribution
41.098.330 10 In distribution
41.098.57 10 In distribution
10.154.1093C In distribution
10.154.3115C In distribution
10.155.3053C 10 In distribution
10.155.3071C 10 In distribution
41.098.1/2 10 In distribution
41.098.701 10 In distribution
10.155.4116F 10 In distribution
41.098.256 10 In distribution
41.098.700L 10 In distribution
10.154.3071C In distribution
41.098.8 10 In distribution
41.098.699 10 In distribution
41.098.1556 10 In distribution
10.154.3118VC In distribution
41.100.001 10 In distribution
10.155.3038C 10 In distribution
10.154.3171VC In distribution
41.101.705 10 In distribution
41.098.699SS 10 In distribution
41.098.7008F 10 In distribution
10.155.3199F 10 In distribution
10.154.3038VC In distribution
10.154.2125 In distribution
10.154.1379F In distribution
10.155.3118F 10 In distribution
41.098.2 10 In distribution
41.098.1558 10 In distribution
10.155.1018C 10 In distribution
10.155.3122C 10 In distribution
10.155.2202C 10 In distribution
10.154.4138VC In distribution
41.098.5 10 In distribution
10.154.2135C In distribution
41.098.332 10 In distribution
41.098.OS702 10 In distribution
41.098.331SS 10 In distribution
41.098.4 10 In distribution
41.098.1158 10 In distribution
41.098.699L 10 In distribution
10.155.4217C 10 In distribution
41.098.246 10 In distribution
10.155.3195F 10 In distribution
10.155.3199EF 10 In distribution
10.154.2068LMC In distribution
10.155.3118C 10 In distribution
41.098.171L 10 In distribution
41.098.7106F 10 In distribution
41.100.004 10 In distribution
41.099.OS6 10 In distribution
41.098.1172 10 In distribution
10.155.1148 10 In distribution
10.154.1192 In distribution
41.098.OS701 10 In distribution
41.098.1170 10 In distribution
10.154.3234C In distribution
10.155.3833C 10 In distribution
41.098.6 10 In distribution
41.098.7642F 10 In distribution
10.154.2096VC In distribution
41.098.34SS 10 In distribution
10.155.4200C 10 In distribution
41.098.OS8 10 In distribution
10.154.1014 In distribution
41.098.1157SS 10 In distribution

Showing 250 of 274 catalogue numbers.

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