Astropol
Astropol F small flame, Astropol F large flame, Astropol F cup, Astropol F disc, Astropol P small flame, Astropol P large flame, Astropol P cup, Astropol P disc, Astropol HP small flame,…
Astropol F small flame, Astropol F large flame, Astropol F cup, Astropol F disc, Astropol P small flame, Astropol P large flame, Astropol P cup, Astropol P disc, Astropol HP small flame, Astropol HP large flame, Astropol HP cup, Astropol HP disc
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 | 2024-04-04 (version 3) |
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 |
| Distribution end date | 2024-04-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 557617 | 6 | Withdrawn | |
| 557616 | 6 | Withdrawn | |
| 557613 | 3 | Withdrawn | |
| 557616 | 6 | Withdrawn | |
| 557614 | 6 | Withdrawn | |
| 557614 | 6 | Withdrawn | |
| 557619 | 6 | Withdrawn | |
| 557620 | 6 | Withdrawn | |
| 557621 | 6 | Withdrawn | |
| 557615 | 6 | Withdrawn | |
| 557620 | 6 | Withdrawn | |
| 557622 | 3 | Withdrawn | |
| 557618 | 6 | Withdrawn | |
| 557624 | 3 | Withdrawn | |
| 557615 | 6 | Withdrawn | |
| 557623 | 3 | Withdrawn | |
| 557625AN | 24 | Withdrawn | |
| 557618 | 6 | Withdrawn | |
| 557625AN | 24 | Withdrawn | |
| 557619 | 6 | Withdrawn | |
| 557621 | 6 | Withdrawn | |
| 557617 | 6 | Withdrawn |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 |
| OptraGloss | Ivoclar Vivadent Aktiengesellschaft | 23 |
| 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.