Benda Micro
Benda Micro Regular Assorted
24manufacturers in China registered for this device type
16catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Hebei (5), Shanghai (4), Anhui (4). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| 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 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
Showing 12 of 24. All 24 manufacturers in China registered for Applicator, Resin
Record
| Listed by | Centrix, Inc., United States |
|---|---|
| FDA product code | KXR |
| Device type | Applicator, Resin |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 380015 | In distribution | |
| 380016 | In distribution | |
| 380020 | In distribution | |
| 380023 | In distribution | |
| 380033 | In distribution | |
| 380005 | In distribution | |
| 380021 | In distribution | |
| 380028 | In distribution | |
| 380014 | In distribution | |
| 380017 | In distribution | |
| 380027 | In distribution | |
| 380013 | In distribution | |
| 380006 | In distribution | |
| 380030 | In distribution | |
| 430020 | In distribution | |
| 380022 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus (Dongguan) Limited | 68 |
| Microbrush | Young Microbrush LLC | 53 |
| Applicator Tips | Pulpdent Corporation | 38 |
| Safco Micro Applicators | Safco Dental Supply | 35 |
| Como Tip | B&L Biotech Co., Inc. | 14 |
| OptraSculpt | Ivoclar Vivadent Aktiengesellschaft | 14 |
| Benda Brush | Centrix, Inc. | 11 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 9 |
| Defend | Young Innovations Inc. | 9 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 8 |
| Accessory | Bisco, Inc. | 8 |
| PlastCare | Proguard Health Inc. | 7 |
Showing 12 of 230. All products under Applicator, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K832662 | 1983-10-04 |
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.