Integra® Miltex®

Integra® Miltex® Carbide Burs, FG, Clinic, 557S

Registry build 21.09.26
46manufacturers in China registered for this device type
162catalogue 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 Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code EJL
Device type Bur, Dental
Device class Class 1
Regulation 21 CFR 872.3240
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-10-25
Record revised 2023-04-27 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Length 28 mm
Distribution end date 2022-05-01

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Per pack Status
DFG330 10 In distribution
DRA1 10 In distribution
DHP331/2 5 In distribution
DFG8SU 10 In distribution
DRA6 10 In distribution
DHP703 5 In distribution
DFG7613-5 5 In distribution
DFG39 10 In distribution
DFG557 10 In distribution
DHP10 5 In distribution
DFG7006-5 5 In distribution
DFG1158 10 In distribution
DRA1/2 10 In distribution
DFG559 10 In distribution
DFG701L 10 In distribution
DFG245 10 In distribution
DHP8 5 In distribution
DFG36 10 In distribution
DFG557S 10 In distribution
DFG35S 10 In distribution
DFG703 10 In distribution
DFG7903-5 5 In distribution
DFG1/4 10 In distribution
DFG7204-5 5 In distribution
DFG2-CL 100 In distribution
DRA701 10 In distribution
DFG7404-5 5 In distribution
DFG7802-5 5 In distribution
DFG701 10 In distribution
DFG7106-5 5 In distribution
DRA331/2 10 In distribution
DFG702 10 In distribution
DRA35 10 In distribution
DFG57L 10 In distribution
DFG557-CL 100 In distribution
DHP1 5 In distribution
DFG7902-5 5 In distribution
DHP558 5 In distribution
DHP559 5 In distribution
DHP557 5 In distribution
DFG557SU 10 In distribution
DHP701 5 In distribution
DRA556 10 In distribution
DFG700L 10 In distribution
DFG559SU 10 In distribution
DFG558SU 10 In distribution
DFG332 10 In distribution
DFG6 10 In distribution
DHP39 5 In distribution
017-33701 Length 28 mm 6 In distribution
DHP6 5 In distribution
DFG557S-CL 100 In distribution
DRA557 10 In distribution
DFG57SU 10 In distribution
DFG329 10 In distribution
DFG38 10 In distribution
DFG58L 10 In distribution
DHP36 5 In distribution
DRA702 10 In distribution
DFG557L 10 In distribution
DFG7104-5 5 In distribution
DFG169L 10 In distribution
DFG1557 10 In distribution
DHP699 5 In distribution
DRA3 10 In distribution
DFG59 10 In distribution
DFG8 10 In distribution
DFG7406-5 5 In distribution
DRA37 10 In distribution
DFG1 10 In distribution
DFG1931-5 5 In distribution
DHP34 5 In distribution
DHP1/2 5 In distribution
DFG7612-5 5 In distribution
DFG1958-5 5 In distribution
DFG1557-CL 100 In distribution
DFG700SU 10 In distribution
DRA5 10 In distribution
DFG1/2SU 10 In distribution
DFG556 10 In distribution
017-33700 Length 28 mm 6 In distribution
DRA700 10 In distribution
DFG560 10 In distribution
DFG1/2-CL 100 In distribution
DFG1/2 10 In distribution
DFG330S 10 In distribution
DFG170 10 In distribution
DHP37 5 In distribution
DHP38 5 In distribution
DFG7408-5 5 In distribution
DFG37 10 In distribution
DFG6-CL 100 In distribution
DRA4 10 In distribution
DFG7901-5 5 In distribution
DFG702SU 10 In distribution
DFG1157-CL 100 In distribution
DFG700 10 In distribution
DFG331L 10 In distribution
DFG331 10 In distribution
DHP560 5 In distribution
DFG171L 10 In distribution
DFG5 10 In distribution
DHP2 5 In distribution
DFG1171 10 In distribution
DFG958 10 In distribution
DFG3 10 In distribution
DFG7611-5 5 In distribution
DFG7713-5 5 In distribution
DFG330-CL 100 In distribution
DFG4 10 In distribution
DFG245-CL 100 In distribution
DFG331/2 10 In distribution
DFG171 10 In distribution
017-33702 Length 28 mm 6 In distribution
DFG556-CL 100 In distribution
DFG7205-5 5 In distribution
DFG2SU 10 In distribution
DHP702 5 In distribution
DFG58SU 10 In distribution
DFG7 10 In distribution
DHP3 5 In distribution
DFG558 10 In distribution
DFG4SU 10 In distribution
DFG57 10 In distribution
DFG1559 10 In distribution
DFG35 10 In distribution
017-33703 Length 28 mm 6 In distribution
DRA558 10 In distribution
DFG558L 10 In distribution
DFG703SU 10 In distribution
DHP556 5 In distribution
DFG1558 10 In distribution
DHP5 5 In distribution
DFG58 10 In distribution
DFG699L 10 In distribution
DFG1558SU 10 In distribution
DRA7 10 In distribution
DFG4-CL 100 In distribution
DFG7108-5 5 In distribution
DFG7702-5 5 In distribution
DHP7 5 In distribution
DFG8-CL 100 In distribution
DFG56 10 In distribution
DFG34 10 In distribution
DFG169 10 In distribution
DFG701SU 10 In distribution
DHP1558 5 In distribution
DFG701-CL 100 In distribution
DFG699 10 In distribution
DFG6SU 10 In distribution
DFG170L 10 In distribution
DHP4 5 In distribution
DFG2 10 In distribution
DHP1/4 5 In distribution
DRA2 10 In distribution
DRA8 10 In distribution
DHP1557 5 In distribution
DHP700 5 In distribution
DFG1157 10 In distribution
DRA34 10 Withdrawn
DHP35 5 Withdrawn
DFG1170 10 Withdrawn

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