3m™ Sof-Lex™
3M™ Sof-Lex™ Extra-Thin Contouring and Polishing Discs Refill, 1/2"Diameter, Superfine, 2382SF
4manufacturers in China registered for this device type
27catalogue 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 | 3M Company, United States |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-17 |
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, manufacturing date |
| Packaging | Box of 10, carton of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1982SF | In distribution | ||
| 1958SF | In distribution | ||
| 1982M | In distribution | ||
| 1981SF | In distribution | ||
| 2381C | In distribution | ||
| 2381F | In distribution | ||
| 2382C | In distribution | ||
| 1981M | In distribution | ||
| 1956 | In distribution | ||
| 1983HP | 3 | In distribution | |
| 1982C | In distribution | ||
| 1958M | In distribution | ||
| 2381M | In distribution | ||
| 1982F | In distribution | ||
| 2382F | In distribution | ||
| 1983FG | In distribution | ||
| 1958F | In distribution | ||
| 1954 | In distribution | ||
| 1983RA | 3 | In distribution | |
| 2380 | In distribution | ||
| 2382M | In distribution | ||
| 1954N | In distribution | ||
| 1981F | In distribution | ||
| 2382SF | In distribution | ||
| 1981C | In distribution | ||
| 1980 | In distribution | ||
| 2381SF | 85 | 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 |
| Praxis | TDV Dental Ltda | 32 |
| 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.