OptraGloss
OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss Kelch HP, OptraGloss Linse HP, OptraGloss Spiralradform HP
4manufacturers in China registered for this device type
23catalogue 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 | Ivoclar Vivadent Aktiengesellschaft |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Premarket notification | Exempt |
| Record published | 2020-08-26 |
| Record revised | 2022-03-17 (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, expiry date, manufacturing date |
| Distribution end date | 2022-02-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 684555AN | 7 | In distribution | |
| 684554AN | 10 | In distribution | |
| 701792WW | 7 | In distribution | |
| 742102WW | In distribution | ||
| 684553AN | 10 | In distribution | |
| 684551AN | 14 | In distribution | |
| 684550AN | 10 | In distribution | |
| 701870AN | In distribution | ||
| 684551AN | 10 | In distribution | |
| 684554AN | 10 | In distribution | |
| 684549AN | 10 | In distribution | |
| 706172WW | In distribution | ||
| 684555AN | In distribution | ||
| 684549AN | 10 | In distribution | |
| 706172WW | 7 | In distribution | |
| 684553AN | 10 | In distribution | |
| 684548AN | 14 | In distribution | |
| 684550AN | 10 | In distribution | |
| 684552AN | 10 | In distribution | |
| 684552AN | 10 | In distribution | |
| 684548AN | In distribution | ||
| 721094AN | 10 | In distribution | |
| 742102WW | 2 | Withdrawn |
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 |
| 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.