SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics and surgical instruments. SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure…
SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics and surgical instruments. SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed. These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for SM-Extra Wide Implant System | Listed by | DIO Corporation, South Korea |
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K080128 |
| Record published | 2015-10-22 |
| Record revised | 2022-02-25 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2022-02-04 |
| UDI direct marking | Exempt |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
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.