Praxis
Praxis - 120 Assorted Discs + Mandrel (PT/ES/EN/FR)
4manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Shofu Dental Material Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | TDV Dental Ltda, Brazil |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 86 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0002000046 | In distribution | |
| 0002000054 | In distribution | |
| 0002000067 | In distribution | |
| 0002000037 | In distribution | |
| 0002000043 | In distribution | |
| 0002000048 | In distribution | |
| 0002000052 | In distribution | |
| 0002000053 | In distribution | |
| 0002000057 | In distribution | |
| 0002000047 | In distribution | |
| 0002000056 | In distribution | |
| 0002000071 | In distribution | |
| 0002000051 | In distribution | |
| 0002000070 | In distribution | |
| 0002000066 | In distribution | |
| 0002000041 | In distribution | |
| 0002000059 | In distribution | |
| 0002000055 | In distribution | |
| 0002000045 | In distribution | |
| 0002000008 | In distribution | |
| 0002000040 | In distribution | |
| 0002000049 | In distribution | |
| 0002000069 | In distribution | |
| 0002000038 | In distribution | |
| 0002000036 | In distribution | |
| 0002000058 | In distribution | |
| 0002000050 | In distribution | |
| 0002000039 | In distribution | |
| 0002000009 | In distribution | |
| 0002000042 | In distribution | |
| 0002000068 | In distribution | |
| 0002000044 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Diamond Coated Dental Discs | M.D.T. – Micro Diamond Technologies Ltd. | 684 |
| Disk, Abrasive | Dentaurum GmbH & Co. KG | 36 |
| 3M™ Sof-Lex™ | 3M Company | 27 |
| Mounted Stones | American Tooth Industries | 26 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 25 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 24 |
| Polishers | DFS-Diamon Gmbh | 24 |
| OptraGloss | Ivoclar Vivadent Aktiengesellschaft | 23 |
| Astropol | Ivoclar Vivadent Aktiengesellschaft | 22 |
| Super-Snap | Shofu Dental Corp. | 19 |
| Sandpaper Discs | TDV Dental Ltda | 15 |
| OptiDisc | Kerr Corporation | 15 |
Showing 12 of 190. All products under Disk, Abrasive
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.