OptiDisc
Finishing and Polishing Discs - Coarse/ Medium - Refill - For Use with Low-Speed Handpiece
4manufacturers in China registered for this device type
15catalogue 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 | Kerr Corporation, United States |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-31 |
| Record revised | 2020-03-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store at or below 25¿C (77¿F) |
| Sizes | Outer diameter 9.6 to 15.9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 33487 | Outer Diameter 15.9 mm | 80 | In distribution |
| 33477 | Outer Diameter 9.6 mm | 80 | In distribution |
| 33478 | Outer Diameter 9.6 mm | 80 | In distribution |
| 33486 | Outer Diameter 15.9 mm | 80 | In distribution |
| 33479 | Outer Diameter 9.6 mm | 80 | In distribution |
| 33484 | Outer Diameter 15.9 mm | 80 | In distribution |
| 33489 | 9.6 mm and 12.6mm each: Extra-Fine, Fine, Coarse/Medium, and Extra-Course | 9 | In distribution |
| 33475 | 9.6 mm and 12.6mm each: Extra-Fine, Fine, Coarse/Medium, and Extra-Course | 243 | In distribution |
| 33488 | 5 | In distribution | |
| 33483 | Outer Diameter 12.6 mm | 80 | In distribution |
| 33476 | Outer Diameter 9.6 mm | 80 | In distribution |
| 33481 | Outer Diameter 12.6 mm | 80 | In distribution |
| 33485 | Outer Diameter 15.9 mm | 80 | In distribution |
| 33480 | Outer Diameter 12.6 mm | 80 | In distribution |
| 33482 | Outer Diameter 12.6 mm | 80 | 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 |
| 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 |
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.