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