Integra® Miltex®
Integra® Miltex® Mandrel, Moore Type, Right Angle, Paper Disc - 12 Pack
4manufacturers in China registered for this device type
12catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EHJ |
| Device type | Disk, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2025-03-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DM350RA | 12 | In distribution | |
| DM516HP | 12 | In distribution | |
| DM3031/2RA | 12 | In distribution | |
| DM303FG | 12 | In distribution | |
| DM303RA | 12 | In distribution | |
| DM321HP | 12 | In distribution | |
| DM321RA | 12 | In distribution | |
| DM313RA | 12 | In distribution | |
| DM350HP | 12 | In distribution | |
| DM303HP | 12 | In distribution | |
| DM313HP | 12 | In distribution | |
| DM3031/2HP | 12 | 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.