Defend
Composite Finishing AND Polishing Strips Regular Fine/Super Fine 100 Pack
46manufacturers in China registered for this device type
237catalogue 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 | Young Innovations Inc., United States |
|---|---|
| FDA product code | EJL |
| Device type | Bur, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3240 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-30 |
| Record revised | 2024-04-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Package of 10, case of 100, inner pack of 100 |
| Distribution end date | 2024-08-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL1956-F/SF | In distribution | |
| FG-558XL | In distribution | |
| SL1954-C/M | In distribution | |
| FG-1/4 | In distribution | |
| 801-023SF | In distribution | |
| FG-1557 | In distribution | |
| SL1956N-F/SF | In distribution | |
| FG-57 | In distribution | |
| 801-023F | In distribution | |
| 856L-014C | In distribution | |
| FG-6XL | In distribution | |
| 856-014SC | In distribution | |
| FG-35 | In distribution | |
| 850-014M | In distribution | |
| 818-030M-5 | In distribution | |
| 859-010F | In distribution | |
| FG-1 | In distribution | |
| SL1954N-C/M | In distribution | |
| RA-35 | In distribution | |
| 830L-012C | In distribution | |
| FG-56 | In distribution | |
| 858-010M | In distribution | |
| 801-010M | In distribution | |
| FG-557S | In distribution | |
| FG-6 | In distribution | |
| FG-37 | In distribution | |
| 848-018SC | In distribution | |
| 379-023SF | In distribution | |
| 862-014SC | In distribution | |
| 879-014C | In distribution | |
| 860-012M | In distribution | |
| 801-018F | In distribution | |
| 835-008C | In distribution | |
| FG-8XL | In distribution | |
| 837-014SC | In distribution | |
| 862-012SC | In distribution | |
| FG-331 | In distribution | |
| 805-012M | In distribution | |
| 835-014M | In distribution | |
| 850-016SC | In distribution | |
| FG-245 | In distribution | |
| 863-016F | In distribution | |
| 856L-018SC | In distribution | |
| FG-330S | In distribution | |
| 878K-016C | In distribution | |
| FG-1157 | In distribution | |
| FG-1158 | In distribution | |
| 392-016M | In distribution | |
| 801-023C | In distribution | |
| 847-016F | In distribution | |
| 802-014M | In distribution | |
| 858-010C | In distribution | |
| 811-033SC | In distribution | |
| FG-4XL | In distribution | |
| 859-012F | In distribution | |
| 836-012M | In distribution | |
| 807-016C | In distribution | |
| FG-1/2 | In distribution | |
| 862-012M | Withdrawn | |
| 860-010SF | Withdrawn | |
| 856-018C | Withdrawn | |
| 878K-012M | Withdrawn | |
| 848-016SC | Withdrawn | |
| 805-016C | Withdrawn | |
| 850-012SC | Withdrawn | |
| 379-018F | Withdrawn | |
| 379-016M | Withdrawn | |
| 863-012M | Withdrawn | |
| 863-016C | Withdrawn | |
| 848-016M | Withdrawn | |
| 850-016C | Withdrawn | |
| 850-016M | Withdrawn | |
| 856-016SC | Withdrawn | |
| 837-012C | Withdrawn | |
| 811-033C | Withdrawn | |
| 836-014M | Withdrawn | |
| 856-021C | Withdrawn | |
| 858-012M | Withdrawn | |
| 847-016C | Withdrawn | |
| 858-010F | Withdrawn | |
| 805-012F | Withdrawn | |
| 379-023M | Withdrawn | |
| 835-009M | Withdrawn | |
| 850-018F | Withdrawn | |
| 368-018SC | Withdrawn | |
| 852-010M | Withdrawn | |
| 835-012M | Withdrawn | |
| 805-016M | Withdrawn | |
| 856-016M | Withdrawn | |
| 806-012M | Withdrawn | |
| 805-010M | Withdrawn | |
| 837-018C | Withdrawn | |
| 368-018M | Withdrawn | |
| 878-014C | Withdrawn | |
| 877-010M | Withdrawn | |
| 856-016F | Withdrawn | |
| 837-016M | Withdrawn | |
| 878-014M | Withdrawn | |
| 850-018C | Withdrawn | |
| 856L-018C | Withdrawn | |
| 885-010M | Withdrawn | |
| 806-014M | Withdrawn | |
| 379-023F | Withdrawn | |
| 847-014C | Withdrawn | |
| 856-018SC | Withdrawn | |
| 858-012C | Withdrawn | |
| 862-014M | Withdrawn | |
| 863-010F | Withdrawn | |
| 836-014C | Withdrawn | |
| 368-023C | Withdrawn | |
| 879-012M | Withdrawn | |
| 379-023SC | Withdrawn | |
| 863-016M | Withdrawn | |
| 836-012SF | Withdrawn | |
| 850-018SF | Withdrawn | |
| 886-016C | Withdrawn | |
| 877K-012M | Withdrawn | |
| 813-014M | Withdrawn | |
| 802-016C | Withdrawn | |
| 850-012C | Withdrawn | |
| 806-014C | Withdrawn | |
| 837-016C | Withdrawn | |
| 878K-012C | Withdrawn | |
| 858-014M | Withdrawn | |
| 837-014C | Withdrawn | |
| 850-010C | Withdrawn | |
| 847-014F | Withdrawn | |
| 862-014SF | Withdrawn | |
| 850-016F | Withdrawn | |
| 856L-016C | Withdrawn | |
| 368-023M | Withdrawn | |
| 848-018C | Withdrawn | |
| 801-012M | Withdrawn | |
| 837-014M | Withdrawn | |
| 379-016F | Withdrawn | |
| 863-012C | Withdrawn | |
| 858-014F | Withdrawn | |
| 379-018C | Withdrawn | |
| 392-016SF | Withdrawn | |
| 837-012M | Withdrawn | |
| 858-012F | Withdrawn | |
| 856-014M | Withdrawn | |
| 802-012M | Withdrawn | |
| 379-018SF | Withdrawn | |
| 368-023SF | Withdrawn | |
| 847-016M | Withdrawn | |
| 886-014C | Withdrawn | |
| 806-012C | Withdrawn | |
| 801-014C | Withdrawn | |
| 850-018M | Withdrawn | |
| 861-014M | Withdrawn | |
| 856-014C | Withdrawn | |
| 878-012C | Withdrawn | |
| 806-010M | Withdrawn | |
| 856-018M | Withdrawn | |
| 862-016C | Withdrawn | |
| 862-014F | Withdrawn | |
| 852-010C | Withdrawn | |
| 835-010M | Withdrawn | |
| 807-014M | Withdrawn | |
| 863-012F | Withdrawn | |
| 801-016M | Withdrawn | |
| 860-010M | Withdrawn | |
| 860-012F | Withdrawn | |
| 878-012M | Withdrawn | |
| 368-018SF | Withdrawn | |
| 368-023SC | Withdrawn | |
| 856L-016M | Withdrawn | |
| 813-016M | Withdrawn | |
| 369-025C | Withdrawn | |
| 813-016C | Withdrawn | |
| 830L-012M | Withdrawn | |
| 847-014M | Withdrawn | |
| 807-016M | Withdrawn | |
| 802-012C | Withdrawn | |
| 862-012SF | Withdrawn | |
| 856L-014M | Withdrawn | |
| 879-012C | Withdrawn | |
| 838-009M | Withdrawn | |
| 863-012SF | Withdrawn | |
| 835-012C | Withdrawn | |
| 805-018F | Withdrawn | |
| 837-018M | Withdrawn | |
| 802-016M | Withdrawn | |
| 850-012M | Withdrawn | |
| 856-025C | Withdrawn | |
| 801-023M | Withdrawn | |
| 379-016C | Withdrawn | |
| 811-037SC | Withdrawn | |
| 859-016F | Withdrawn | |
| 368-020C | Withdrawn | |
| 811-037C | Withdrawn | |
| 863-010M | Withdrawn | |
| 848-016C | Withdrawn | |
| 877-010C | Withdrawn | |
| 850-018SC | Withdrawn | |
| 856L-018F | Withdrawn | |
| 813-014C | Withdrawn | |
| 801-018M | Withdrawn | |
| 856-016C | Withdrawn | |
| 392-016F | Withdrawn | |
| 878K-016M | Withdrawn | |
| 885-010C | Withdrawn | |
| 847-018M | Withdrawn | |
| 862-014C | Withdrawn | |
| 801-012C | Withdrawn | |
| 856L-016SC | Withdrawn | |
| 806-010C | Withdrawn | |
| 801-016C | Withdrawn | |
| 806-016M | Withdrawn | |
| 856-012SC | Withdrawn | |
| 886-012C | Withdrawn | |
| 856L-018M | Withdrawn | |
| 379-018M | Withdrawn | |
| 850-014C | Withdrawn | |
| 862-012C | Withdrawn | |
| 368-018C | Withdrawn | |
| 879-014M | Withdrawn | |
| 861-012F | Withdrawn | |
| 858-014C | Withdrawn | |
| 368-023F | Withdrawn | |
| 379-023C | Withdrawn | |
| 368-018F | Withdrawn | |
| 802-014C | Withdrawn | |
| 861-012M | Withdrawn | |
| 856-018F | Withdrawn | |
| 862-012F | Withdrawn | |
| 848-010M | Withdrawn | |
| 861-016M | Withdrawn | |
| 801-018C | Withdrawn | |
| 862-016F | Withdrawn | |
| 856-012C | Withdrawn | |
| 850-014SC | Withdrawn | |
| 801-014M | Withdrawn | |
| 862-016M | Withdrawn | |
| 806-016C | Withdrawn | |
| 885-012C | 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.