Palodent® Sectional Matrix System
Palodent Sectional Matrix System 2 BiTine II Oval Rings Refill
64manufacturers in China registered for this device type
8catalogue 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 |
| Record published | 2019-04-02 |
| Record revised | 2022-10-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry.; Storage environment temperature 10 to 24 °C |
| Distribution end date | 2024-05-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 659015 | 50x Standard Matrices | 50 | In distribution |
| 659040 | 4x BiTine® Round Rings | 4 | In distribution |
| 659020 | 50x Mini Matrices | 50 | In distribution |
| 659010 | 100x Standard Matrices | 100 | In distribution |
| 659500 | 1x BiTine® Ring Placement Forceps | Withdrawn | |
| 659030 | 50x Large Matrices | 50 | Withdrawn |
| 659050 | 2x BiTine® II Oval Rings | 2 | Withdrawn |
| 659070 | 50x Standard Matrices, 2x BiTine® Round Rings | Withdrawn |
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.