Disk, Abrasive
Grinding points, pink, medium hardness, medium grain size, Form: conical, wheel, inverted conical and conical, proximal concave
4manufacturers in China registered for this device type
36catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-28 |
| Record revised | 2025-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2025-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 137-850-00 | In distribution | ||
| 130-113-00 | 20 | In distribution | |
| 130-103-00 | 10 | In distribution | |
| 130-113-40 | 40 | In distribution | |
| 132-203-00 | 100 | In distribution | |
| 130-324-00 | 100 | In distribution | |
| 130-103-40 | 40 | In distribution | |
| 132-202-00 | 100 | In distribution | |
| 130-102-40 | 40 | In distribution | |
| 132-804-00 | 100 | In distribution | |
| 132-201-00 | 100 | In distribution | |
| 130-137-00 | 100 | In distribution | |
| 132-802-00 | 100 | In distribution | |
| 130-111-00 | 20 | In distribution | |
| 130-138-00 | 100 | In distribution | |
| 130-102-00 | 10 | In distribution | |
| 130-101-00 | 10 | In distribution | |
| 137-855-00 | In distribution | ||
| 132-801-00 | 100 | In distribution | |
| 134-000-00 | 12 | In distribution | |
| 130-111-40 | 40 | In distribution | |
| 130-112-00 | 20 | In distribution | |
| 130-512-00 | 100 | In distribution | |
| 130-131-00 | 50 | In distribution | |
| 132-803-00 | 100 | In distribution | |
| 130-112-40 | 40 | In distribution | |
| 132-205-00 | 100 | In distribution | |
| 137-856-00 | In distribution | ||
| 130-824-00 | 100 | In distribution | |
| 130-101-40 | 40 | In distribution | |
| 131-322-50 | 100 | In distribution | |
| 130-114-00 | 20 | In distribution | |
| 130-634-00 | 25 | In distribution | |
| 130-115-00 | 10 | In distribution | |
| 135-500-00 | Withdrawn | ||
| 132-204-00 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Diamond Coated Dental Discs | M.D.T. – Micro Diamond Technologies Ltd. | 684 |
| Praxis | TDV Dental Ltda | 32 |
| 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.