Palodent® 360
Palodent® 360 Intro Kit with Palodent® Plus
64manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| medmix China Ltd | Shanghai | Shanghai | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| 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 |
Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature.; Special storage condition: Keep away from moisture or excessive humidity.; Storage environment temperature 2 to 24 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 659603 | 48 Matrices, Size 6.5mm (Light Blue) | 48 | In distribution |
| 659600V | 100 Matrices, 75 Wedges, 30 WedgeGuards | In distribution | |
| 659606 | 5 Matrices (5.5mm) | 5 | In distribution |
| 659602 | 48 Matrices, Size 5.5mm (Blue) | 48 | In distribution |
| 659600 | 100 Matrices, 75 Wedges, 30 WedgeGuards | In distribution | |
| 659601 | 48 Matrices, Size 4.5mm (Dark Blue) | 48 | In distribution |
| 659607 | 48 Matrices (8 of 4.5mm, 24 of 5.5mm, 16 of 6.5mm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMDental | LM-Dental | 936 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 544 |
| Instruments, Dental Hand | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 307 |
| Power Dental USA | Power Dental U.S.A. Inc. | 209 |
| Supremo Instrumentos | Andre Gregate Braga Instrumentos Ltda | 95 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 92 |
| Diamodent | Diamodent | 81 |
| Stoma® | Storz AM Mark Gmbh | 80 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 77 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 67 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 58 |
Showing 12 of 1,362. All products under Instruments, Dental Hand
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K822094 | 1982-08-16 |
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.