Misc
Spatula Disposable PK 75
24manufacturers in China registered for this device type
1catalogue number
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 | Ormco Corporation, United States |
|---|---|
| FDA product code | KXR |
| Device type | Applicator, Resin |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3140 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-07 |
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 |
|---|---|---|
| 740-0042 | 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 |
| Benda Micro | Centrix, Inc. | 16 |
| 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 |
Showing 12 of 230. All products under Applicator, Resin
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.